Efficacy of a Fluralaner-based Ectoparasiticide, for the Control of Otodectic and Sarcoptic Mange in Naturally Infested Dogs, Evaluated in Randomized, Double-Blind Clinical Studies

Efficacy of a Fluralaner-based Ectoparasiticide, for the Control of Otodectic and Sarcoptic Mange in Naturally Infested Dogs, Evaluated in Randomized, Double-Blind Clinical Studies | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy of a Fluralaner-based Ectoparasiticide, for the Control of Otodectic and Sarcoptic Mange in Naturally Infested Dogs, Evaluated in Randomized, Double-Blind Clinical Studies Breno Cayeiro Cruz, Marina Belucci Teixeira, Gessica Ariane de Melo Cruz, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7658451/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 22 Feb, 2026 Read the published version in Parasites & Vectors → Version 1 posted 9 You are reading this latest preprint version Abstract Background Parasitic dermatopathies account for approximately 30% of cases in veterinary clinics, primarily caused by ticks, fleas, and mites. Parasitic mites cause mange, a term used to describe a type of skin disease. One of the most relevant parasitic Acari is Sarcoptes scabiei , which causes sarcoptic mange, mainly called scabies in humans. This condition is highly contagious, affects various mammals and humans, leading to intense itching and skin lesions. Another significant mite is Otodectes cynotis , the "ear mite", which is the primary cause of external otitis in mammals, causing severe ear itching. The treatment and control of these forms of mange rely on the use of antiparasitics, such as fluralaner, which acts by paralyzing and killing the parasites. Methods Two clinical studies were conducted to evaluate the acaricide efficacy against these mites. Both studies utilized 14 animals each, divided into a Control Group (n = 7), treated with a reference product based on sarolaner, and a Treated Group (n = 7) treated with WellPet™ (a palatable tablet based on fluralaner, 10 to 22.5 mg/kg – Ourofino Saúde Animal Ltda.). Acaricide efficacy was assessed through mite counts and evaluation of lesions resulting from the diseases. Results There was no statistical difference in the comparison between the Treated and Control groups in either trial. WellPet™ demonstrated 100% efficacy against sarcoptic mange after a single administration, unlike the reference product, which required two monthly administrations. For otodectic mange, both products reached adequate efficacy after a single use. Conclusions The WellPet™ product, a novel ectoparasiticide based on fluralaner, proved to be highly effective in the treatment of both sarcoptic and otodectic mange, with results similar to those of sarolaner. The main advantage of WellPet™ is the ability to achieve complete cure of sarcoptic mange with a single dose, thereby simplifying disease management. For otodectic mange, both products were highly effective. In summary, WellPet™ is an effective and practical treatment option for these types of mange. Acaricide Isoxazoline Mites Otodectes cynotis Sarcoptes scabiei Treatment Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Background Parasitic dermatopathies are caused by ectoparasites such as ticks, fleas, and mites, the latter being primarily responsible for clinical cases of mange in domestic animals. The most clinically relevant mites include Sarcoptes scabiei (DE GEER, 1778) and Otodectes cynotis (HERING, 1838). Sarcoptic mange, also known as scabies, is a highly contagious parasitic dermatopathy, affecting a wide variety of mammals, including dogs, cats, production animals, and humans (BERIAN, 2018). Its etiological agent is the mite S. scabiei , originally described as Acarus scabiei , which belongs to the subclass Acari , superorder Acariformes, order Sarcoptiformes, superfamily Sarcoptoidea, family Sarcoptidae (ARLIAN & MORGAN, 2017). S. scabiei forms, to some extent, species-specific and host-adapted varieties, infecting canids, felids and ungulates, but a variety of other animal groups are also infected (KRAABØL et al. , 2015). This mite does not show a preference for breed, sex, or age (ARLIAN & MORGAN, 2017). The infection causes severe pruritic dermatitis, characterized by hemorrhagic crusts, alopecia, skin thickening, and, in chronic cases, foul odor and lymphadenopathy (ANDRADE et al ., 2017; BORNSTEIN et al ., 2001). The disease tends to manifest more severely in immunosuppressed, malnourished, or vulnerable animals, such as stray dogs or those housed in zoonosis control centers (BARROS et al ., 2019). In addition to its impact on animal welfare, sarcoptic mange can represent a zoonotic risk, especially in contexts of close coexistence between humans and domestic animals. However, it is important to note that S. scabiei exhibits host specificity, and the variant most commonly found in dogs, S. scabiei var. canis , is now recognized as being highly adapted to canids (ARLIAN & MORGAN, 2017). Another ectoparasite of clinical importance is the mite O. cynotis , originally described as Sarcoptes cynotis , belonging also to the subclass Acari , superorder Acariformes, order Sarcoptiformes, superfamily Sarcoptoidea, from the Psoroptidae family, popularly known as the “ear mite”. It is the etiological agent of otodectic mange, one of the main causes of external otitis in mammals such as dogs and cats (WAN, 2017). These mites predominantly inhabit the surfaces of the ear canal, but may also be found in other regions including the head, paws, and tail tip. Their presence induces intense pruritus and head shaking, which, in more severe cases, can result in lacerations and auricular hematomas. Heavy infestations may predispose animals to secondary fungal and bacterial infections. Clinical signs include bilateral pruritic otitis, presence of dry dark brown cerumen, and self-induced lesions on the ear, face, and neck (CARMONA, 2020). The control of sarcoptic and otodectic mange depends on preventive and therapeutic measures. As with all other ectoparasites, the use of chemical compounds, administered orally, topically (spraying, immersion, pour-on, spot-on, impregnated ear tags or collars), or parenterally (subcutaneous), constitutes the basis of their control (ANDREOTTI; KOLLER; GARCIA, 2016). Effective control of mange causing mites should be focused on products that provide sufficient duration of activity to ensure that any eggs hatching subsequent to treatment do not produce viable larvae, and to prevent environmental re-infestation. A systemically acting miticide with a sustained activity is, therefore, an important tool in the treatment and control of mange (CHIUMMO et al. , 2020). Among the available antiparasitics, fluralaner stands out, an isoxazoline with proven efficacy against a wide range of ectoparasites, such as fleas, ticks, dipterans, and mange-causing mites (PAPICH, 2020). Isoxazolines are a chemical class introduced in the 2000s, with three active principles initially approved for veterinary use: afoxolaner, fluralaner, lotilaner, and sarolaner, all of which act as systemic insecticides and acaricides. They are rapidly absorbed and reach peak plasma concentrations within 24 hours, being mainly distributed in tissues such as fat, liver, kidneys, and muscles, and slowly eliminated primarily through feces (SPINOSA et al ., 2017). At nanomolar concentrations, fluralaner acts as a potent blocker of ligand-gated chloride channels, mainly GABA-gated (gamma-aminobutyric acid), as well as GLU-gated (glutamate) chloride channels, the former being exclusive to arthropods. This action prevents the influx of chloride ions into the postsynaptic tissue, leading to depolarization, paralysis, and death of the parasite (OZOE et al ., 2010; GASSEL et al ., 2014). In addition to its potency and selectivity, fluralaner has a unique molecular structure compared to other known chloride channel blockers, having a distinct mode of action on the inhibition of the RDL (“resistant to dieldrin”, one subunit of GABA receptors able to form functional pentameric ligand-gated ion channels, which consists of a long N-terminal extracellular domain and four transmembrane regions, being an important target for various insecticides) subunit of the receptor, with a different binding site in the RDL (ZHOU et al. , 2025). Fluralaner is widely recognized, in scientific literature, as an adequate alternative for controlling both S. scabiei and O. cynotis on a variety of mammals. S. scabiei is a global threat to wildlife, being documented in more than 200 mammalian species. Infections can be fatal if not treated. At the dosage of 25 to 56 mg/kg, fluralaner was able to control these mites in dogs (both mites), cats (only O. cynotis ), rabbits, maned wolves, raccoon dogs, bare-nosed wombats, koalas and alpacas (only S. scabiei in all these mammals). However, there are still doubts regarding safety of fluralaner at this dosages, with reported side effects in dogs including vomiting, decreased appetite, diarrhea, lethargy, polydipsia, flatulence, diffuse non-itchy erythematous papules, loss of appetite, pruritis, coughing, mild erythema and mild wheal development (topical use), higher rectal temperatures, lymphedema, pemphigus foliaceus (cutaneous autoimmune disease), and even severe neurological toxicity (difficulty walking and balancing, oral dysphagia, muscle twitching, head and body tremors, myoclonic jerks and generalized ataxia (JIANG & OLD, 2025). Therefore, evaluating the therapeutic response to fluralaner-based commercial product, at a safer dose range, against major ectoparasites of domestic animals, such as S. scabiei and O. cynotis , is a key step toward the proper management of the diseases caused by these mites, and the reduction of its impact on both animal and public health. Methods Two positive-controlled, double blind, randomized, and multicenter clinical trials were conducted to determine the acaricide efficacy of WellPet™ (Ourofino Saúde Animal Ltda.), a new commercial palatable tablet based on fluralaner, at a dose range of 10 to 22.5 mg/kg, against S. scabiei and O. cynotis mites parasitizing naturally infested domestic dogs. Both trials were conducted in accordance with international guidelines for good clinical practices, as established in the Guidance for Industry: Good Clinical Practice (VICH GL9). Furthermore, national regulations regarding the use of animals in scientific research were followed, including Law No. 11,794/2008 (Arouca Law), regulated by Decree No. 6,899/2009, as well as the guidelines of the National Council for the Control of Animal Experimentation (CONCEA), as per the Brazilian Guide for the Production, Maintenance or Use of Animals in Teaching or Scientific Research Activities (2023), especially Chap. 14, which deals with studies conducted with domestic animals kept outside teaching or research institutions. The appropriate Animal Use Ethics Committee previously approved both trials. At each study site, activities were distributed between a non-blinded Dispenser, responsible for assigning and administering treatments, but who did not participate in clinical evaluations, and a blinded Examiner, who performed all treatment-related observations. Common points in both studies evaluating the acaricide efficacy of WellPet™ against sarcoptic and otodectic mange In each trial, 14 animals were included. To be eligible for inclusion, animals had to be over 12 months of age, weighing more than 2 kg, being microchipped for identification and free from health conditions unrelated to S. scabiei or O. cynotis infestations. Additionally, they had to be infested with at least five live mites (for O. cynotis , animals had to be bilaterally infested with an average of at least five live mites across both ears) and have owner consent confirmed through a signed informed consent form. Animals showing any clinical signs of disease, undergoing medical treatment, having received any medication other than vaccines and anthelmintics within 30 days prior to the start of the study, or being overly aggressive/reactive, would be excluded. All animals were alone in their respective environments, with no contactant animals. During the study, walks, baths, parasite control, contact with animals outside the study, and unauthorized concomitant medications, including anthelmintics, were not permitted. The main criterion for evaluating the product's efficacy in each trial was the parasitological cure rate, calculated as the proportion of dogs that showed negative results for S. scabiei or O. cynotis . Efficacy was calculated, using the adapted Abbott's formula, at each post-treatment date (CHAVÉZ, 2016; FOURIE et al. , 2015): Efficacy Percentage (%) = {(mean live mite counts in animals on D-1) - (mean live mite counts on D + X) ÷ (mean live mite counts in animals on D-1)} x 100 At this formula, D + X refers to each of the post-treatment counts. For a product to be considered adequate acaricide, its calculated efficacy must be at least above 90% (MAPA, 2020). All data generated in each study were statistically evaluated using Student's t-test (parametric) or Mann-Whitney (non-parametric) for comparisons between groups and between treatment times. Intragroup comparisons were also performed using the paired t-test (parametric) or Wilcoxon test (non-parametric), depending on data distribution. Statistical tests were performed with the aid of both the SPSS program, version 22, developed by IBM (2013) and the Minitab® Statistical Software (© 2025 Minitab, LLC.). Statistical significance would be considered when the p-value was less than 5% (p\<0.05). Determination of adequate Sample Sizes (“N”): The Experimental Power Graphing Program spreadsheet was used when designing the protocols. This is a tool which assists in determining the power of a test and consequently defining the appropriate number of repetitions, as part of the programs made available by the University of Georgia, in Bulletin 1491 of its extension publications (Three Workbooks to Help Estimate Experimental Power and Normalize Experimental Data), to estimate the experimental power of a study and normalize experimental data (PESTI et al ., 2018). Counts of animals parasitized by Sarcoptoidea mites, in previous recent studies conducted by the same researchers, were selected. The mean data from these counts (average of 11 mites per animal, with a standard deviation of 4,0) were corroborated by data from published literature studies evaluating efficacy against mites (TAENZLER et al ., 2016; CHIUMMO et al ., 2020). Mean and standard deviation data were used without applying any transformation, which already met the normality assumption in the distribution. In the program, the specific tab for data with a constant coefficient of variation (CV) was used, as the standard deviations of mite counts vary proportionally to the mean values observed at each time point. This approach generally indicates the need for a larger number of units to achieve the desired experimental power, with the estimate considered more conservative. As a confidence level, 0.05 (α = 0.05, i.e., 95% confidence interval) was considered, and 0.8 (1-β = 80%) as the desired power for the test. With these data, the power of the test was then calculated for each different hypothesis (percentage of mite reduction at each post-treatment time point, compared to the initial means of the respective groups) and for various numbers of repetitions (simulated numbers of dogs per experimental group) as shown in Table 1 . Table 1 Power of the test calculated for each hypothesis (percentage of difference between mite counts and distinct potential number of repetitions evaluated), considering a confidence level of 0.05 (α = 0.05, i.e., 95% confidence interval) and 0.8 (1-β = 80%) as the minimum acceptable power for the test. Percent difference Sample size (n per group) 2 3 4 5 6 7 8 9 10 11 -50% 0.075 0.281 0.506 0.666 0.775 0.848 0.898 0.932 0.955 0.970 -55% 0.084 0.362 0.618 0.771 0.862 0.917 0.950 0.970 0.982 0.989 -60% 0.095 0.457 0.721 0.853 0.921 0.957 0.977 0.988 0.993 0.996 -65% 0.109 0.557 0.806 0.910 0.957 0.979 0.990 0.995 0.998 0.999 -70% 0.126 0.653 0.870 0.947 0.978 0.990 0.996 0.998 0.999 0.999 -75% 0.149 0.737 0.915 0.969 0.988 0.996 0.998 0.999 0.999 0.999 -80% 0.178 0.806 0.945 0.982 0.994 0.998 0.999 0.999 0.999 1.000 -85% 0.214 0.858 0.964 0.990 0.997 0.999 0.999 0.999 1.000 1.000 -90% 0.257 0.896 0.976 0.994 0.998 0.999 0.999 1.000 1.000 1.000 The simulation results indicated that a minimum of seven ( 7 ) repetitions per group was sufficient to detect differences in mite quantification (efficacy) of 50% or greater as statistically significant, with a confidence level exceeding 95%. Thus, a minimum of seven animals per group was considered fully adequate for the execution of the present assays, in accordance with all reference guidelines. This sample size ensured the statistical robustness of the experimental model while adhering to the principle of using the 'minimum number of necessary animals' Additionally, the sample size of seven animals per group is consistent with previously published efficacy studies for mange treatments in dogs, which frequently utilize samples of similar or slightly larger size to demonstrate significant results. For instance, studies such as Andrade et al . (2017), Carithers et al . (2016), and Taenzler et al . (2016) employed a comparable number of animals per group to evaluate the efficacy of different treatments for parasitic infestations. Study 1: Evaluation of the acaricide efficacy of WellPet TM for the control of sarcoptic mange in dogs naturally infested by Sarcoptes scabiei 14 animals were included in the study, comprising 42.9% males (6/14) and 57.1% females (8/14), with a mean age of 4.7 years (animals aged 1 to 9 years). The 14 animals were divided into two groups: the Treated Group (n = seven) and the Positive Control Group (n = seven). Animals in the Treated Group received WellPet™ (Ourofino Saúde Animal Ltda.) orally on Day 0 (D0), at the dose recommended in the package insert, which provides a minimum of 10 mg/kg of fluralaner. Animals in the Positive Control Group received a reference oral antiparasitic product containing at the recommended dose, corresponding to a minimum of 2 mg/kg of fluralaner. On days + 3, +7, + 14, +21, + 28 after treatment, clinical evaluations, acaricide efficacy evaluations, and dermatological evaluations were performed. If mites were still present on Day 28 (D + 28) - i.e., if the final post-treatment assessment revealed at least one live mite - a second treatment was administered on Day 30 (D + 30), in accordance with the monthly dosing schedule recommended for both WellPet™ and the reference product. Following the second treatment, if and when needed, new evaluations were conducted, on Days + 33, +37, + 44, +51, and + 58. To evaluate acaricidal efficacy, at each moment, mites were collected and counted via skin scrapings from five areas of each animal. At least 2.5 cm² (≈ 0.39 sq in) of skin showing evidence of active mite infestation was scraped until capillary bleeding occurred. A veterinarian, blinded to the treatment group, performed the parasitological examination, quantifying adult and immature S. scabiei mites under 10× magnification. Dermatological assessment of lesion severity was conducted prior to sample collection in two areas, based on the following parameters: pruritus, erythema, papules, excoriations, crusts, alopecia, and pyoderma. Study 2: Evaluation of the acaricide efficacy of WellPet™ for the control of sarcoptic mange in dogs naturally infested by Otodectes cynotis Another 14 animals were included in this study, comprising once again 42.9% males (6/14) and 57.1% females (8/14), with a mean age of 4.7 years (animals aged 1 to 10 years). The 14 animals were also divided into two groups: Treated Group (n = seven) and Positive Control Group (n = seven), using the same products and doses as in Study 1. Clinical evaluations, acaricide efficacy evaluations, and dermatological evaluations of skin lesions also followed the same criteria and evaluation days as the first trial. However, for the evaluation of skin lesions, indirect assessments were conducted to identify the presence or absence of clinical signs associated with otodectic mange, such as head shaking, pruritus, trauma or alopecia, erythema, ulceration, and debris, among others. To evaluate acaricidal efficacy, each count was preceded by the collection of material from both ear canals (right and left), as well as skin scrapings of the external and middle ear (approximately 1 cm² [≈ 0.16 sq in]). Evaluations of the left and right sides were performed separately to ensure bilateral infestation. The total number of live mites from both sides was considered the final count for each animal. Additionally, in all evaluations, the number of O. cynotis eggs present was also recorded. For the collection of material from the ear canals, a swab was used to gently remove debris. Mite and egg counts were recorded per slide, and subsequently, the arithmetic and geometric means were calculated for each animal. For microscopic examination, the material collected from each side (ear canal and scraping) was spread on a slide and analyzed to detect mites and eggs. Results Confirmation of adequacy of Sample Sizes (“N”): After the studies were finished, pre-treatment data was compiled and calculations using the Experimental Power Graphing Program spreadsheet (PESTI et al ., 2018) were repeated with the real data obtained on each trial (average of 12.86 S. scabiei mites before treatment, with a standard deviation of 3.63; and average of 17.14 O. cynotis mites before treatment, with a standard deviation of 6.74). With a confidence level of 0.05 and a desired power of 0.8, a minimum of seven repetitions per group was confirmed as sufficient to detect differences in mite quantification (inferiority in efficacy indexes) of 50% or greater as statistically significant (for O. cynotis , differences of 40% or greater would be identified as statistically significant). Study 1 - Sarcoptes scabiei : Regarding the clinical condition of animals, the occurrence of abnormal clinical signs was observed. However, these were only changes resulting from verminosis or stress of the animals at the time of clinical evaluations. Some animals presented Grade 2 (mild) dehydration (3 to 4 seconds), regarding capillary refill time (CRT). However, by the end of the study, these returned to normality. Additionally, all animals exhibited normal behavior throughout the whole trial. After the first negative result for each animal’s Acari counts, confirmation was obtained through additional skin scrapings, performed at weekly day intervals, totaling three consecutive negative results. At the end of the 30-day evaluation period, after the first treatments, two animals in the Control Group still tested positive for mites, requiring a second sarolaner administration. No animals treated with WellPet™ needed a second fluralaner administration. Figure 01 presents the mean mite counts for each group at each experimental time point. Statistical analysis of the total mite counts per animal (Table 2 ) revealed distinct intragroup trends. The Control group showed a statistically significant reduction in mite counts from Day 7 (p = 0,045) onwards, while the WellPet TM -treated group reached statistical significance starting from Day 14 (p = 0,022). Nonetheless, WellPet™ achieved full 100% efficacy by Day 28, without the need for re-treatment. The Control Group, however, required re-treatment for two animals to reach 100% efficacy by Day 44. Intergroup comparison showed no statistically significant differences (p > 0.05). These results confirm WellPet™'s effectiveness, surpassing the minimum threshold of 90% efficacy (MAPA, 2020), completely controlling S. scabiei infestations four weeks after a single administration. Table 2 Scabicidal efficacy results (Mite Count) against S. scabiei and Intragroup and Intergroup Statistical Analyses of Treated Groups. Time point (Day) Group 1 – WellPet™ (single oral dose of fluralaner – 10 to 22.5 mg/kg) Group 2 – Control (single oral dose of sarolaner, repeated after 30 days if necessary) Intergroup p-value Mean ± SD (N) Efficacy percentages Intragroup ( vs day − 1) p-value Mean ± SD (N) Efficacy percentages Intragroup ( vs day − 1) p-value Group comparison D-1 14.00 ± 6.24 (n = 7) - - 12.86 ± 3.63 (n = 7) - - p = 0.683 D + 3 11.71 ± 8.06 (n = 7) 16.3% p = 0.152 8.86 ± 6.01 (n = 7) 36.7% p = 0.103 p = 0.467 D + 7 7.57 ± 8.10 (n = 7) 45.9% p = 0.082* 6.29 ± 6.87 (n = 7) 51.1% p = 0.045* p = 0.754 D + 14 3.14 ± 4.71 (n = 7) 77.5% p = 0.022* 3.00 ± 3.06 (n = 7) 76.7% p = 0.003* p = 0.947 D + 21 0.29 ± 0.76 (n = 7) 81.6% p = 0.022* 1.43 ± 2.44 (n = 7) 88.9% p = 0.022* p = 0.259 D + 28 0.00 ± 0.00 (n = 7) 100% - a 1.71 ± 2.98 (n = 7) 86.7% p = 0.022* p = 0.154 D + 33 0.00 ± 0.00 (n = 3) 100% - a 2.75 ± 3.20 (n = 4) 91.1% p = 0.01* p = 0.149 D + 44 - a 100% - a 0.00 ± 0.00 (n = 2) 100% - a - a D + 51 - a - a - a 0.00 ± 0.00 (n = 2) 100% - a - a D + 58 - a - a - a 0.00 ± 0.00 (n = 2) -* - a - a Legend: * Statistically significant; a Not enough data to assess normality; statistical analysis not applicable. In the evaluation of skin lesions resulting from sarcoptic mange, no statistically significant differences were observed between the groups for any of the analyzed variables throughout the study. From D + 28 onwards, pruritus was completely absent in animals treated with WellPet™. In contrast, animals in the Control Group only achieved total absence of pruritus by D + 37. Similarly, erythema resolved entirely in the Treated Group by D + 14 and remained absent until the end of the study, whereas in the Control Group, complete resolution was only observed starting from D + 28. Excoriations disappeared entirely in the Treated Group as early as D + 14 (Fig. 02 ), while in the Control Group, this occurred only by D + 21. In both cases, erythema was not detectable anymore even before total elimination of S. scabiei infestations. Regarding crusted lesions (Fig. 03 ), total resolution was observed on D + 14 in the Treated Group and even earlier in the Control Group, on D + 7. Finally, alopecia was completely resolved in the Treated Group by D + 37, while in the Control Group, full recovery was only observed at the end of the study, on D + 58. For alopecia, as expected, complete resolution only happened after total elimination of Acari infestations. Study 2 - Otodectes cynotis : Regarding the clinical picture, only the occurrence of abnormal clinical signs related to a positive diagnosis for O. cynotis were observed. At the end of the thirty (30) days of evaluation, after treatment of animals with single dosages of each product, all animals in both groups showed negative results for mites, confirmed in at least three consecutive negative collections. Therefore, no second treatment was required for any animal. A small number of animals from each group still had mites detected on D + 14, and only began to show complete negativity from D + 21 — specifically, two dogs in the Treated Group and three in the Control Group. For these animals, an additional evaluation on D + 33 was necessary to complete the three required negative assessments. WellPet™ demonstrated 94,1% efficacy as early as day 14, reaching 100% from day 21. Figure 04 presents the means mite counts for each group at each experimental time point. Upon analyzing the mite count data, which represents the final average count from the right and left ears, statistical results are summarized in Table 3 . In the intragroup analysis, the Treated group demonstrated a statistically significant reduction in mite counts compared to baseline as early as Day 3 post-treatment (p = 0,036). The Control group, in turn, achieved a statistically significant reduction from Day 7 (p = 0,022) onwards. Though the Control group achieved 100% efficacy first, by Day 14, in the intergroup analysis, no statistically significant differences were observed between the groups (p > 0.05). Furthermore, egg count data, presented in Fig. 05 , also showed no statistically significant differences between the groups. As this parameter served only as a complementary factor for the efficacy assessment, and not as a primary outcome variable, intragroup analysis was not performed. Table 3 Scabicidal efficacy results (Mite Count) against O. cynotis and Intragroup and Intergroup Statistical Analyses of Treated Groups Time point (Day) Group 1 – WellPet™ (single oral dose of fluralaner – 10 to 22.5 mg/kg) Group 2 – Control (single oral dose of sarolaner, repeated after 30 days if necessary) Intergroup p-value Mean ± SD (N) Efficacy percentages Intragroup ( vs day − 1) p-value Mean ± SD (N) Efficacy percentages Intragroup ( vs day − 1) p-value Group comparison D-1 17.14 ± 6.74 (n = 7) - - 13.00 ± 8.10 (n = 7) - - p = 0,319 D + 3 12.43 ± 7.02 (n = 7) 29,4% p = 0,036* 7.71 ± 2.93 (n = 7) 38,5% p = 0,053 p = 0,127 D + 7 4.38 ± 3.53 (n = 7) 70,6% p = 0,001* 2.86 ± 1.21 (n = 7) 76,9% p = 0,022* p = 0,182 D + 14 1 ± 1.41 (n = 7) 94,1% p = 0,022* 0.29 ± 0.49 (n = 7) 100% p = 0,022* p = 0,23 D + 21 0.00 ± 0.00 (n = 7) 100% - a 0.00 ± 0.00 (n = 7) 100% - a - a D + 28 0.00 ± 0.00 (n = 7) 100% - a 0.00 ± 0.00 (n = 7) 100% - a - a D + 33 0.00 ± 0.00 (n = 3) 100% - a 0.00 ± 0.00 (n = 2) 100% - a - a Legend: * Statistically significant; a Not enough data to assess normality; statistical analysis not applicable. In the evaluation of skin lesions resulting from otodectic mange, there was no statistical difference for any of the analyzed variables. However, it is worth noting that, despite the resolution of other dermatological signs by the end of the study, some animals in both groups still exhibited mild alopecia. The persistence of alopecia in these two animals is likely due to the fact that hair regrowth is a dermatological process that requires a longer recovery period. It is also noteworthy that, from D + 7, erythema was already completely absent in the group treated with WellPet™, whereas in the Control Group, this was only observed from D + 14. Both treatments achieved 100% acaricidal efficacy with a single application, as evidenced by the complete elimination of mites confirmed through consecutive weekly counts, along with full remission of clinical signs associated with otodectic mange (Fig. 06). Discussion In the treatment of sarcoptic mange, WellPet™ demonstrated high efficacy in the animals evaluated in this study, achieving 100% parasitological control 28 days after all animals were treated with a single administration of this product, in a dose of 10 to 22.5 mg/kg of fluralaner. Furthermore, complete remission of associated clinical signs, such as pyoderma, pruritus, erythema, excoriations, crusts, and alopecia, was observed, with no animal in the study requiring readministration until the end of the follow-up period (D + 58). Although no statistically significant differences were observed compared to the Control Group, the latter only achieved complete efficacy after the second administration, demonstrating a practical advantage of WellPet™ in terms of therapeutic convenience. The findings are consistent with the literature. Taenzler et al . (2016) demonstrated that a single dose of fluralaner, administered orally or topically, resulted in 100% reduction in S. scabiei counts after four weeks. Similarly, Chiummo et al. (2020) reported that over 90% of dogs were mite-free on day 28, with 100% efficacy on days 56 and 84, lasting up to 12 weeks. In the same study, the control group treated with sarolaner required two administrations (days 0 and 28) to achieve complete mite elimination on days 56 and 84 — a treatment approach that was also necessary in the present study to ensure full resolution in some animals. Similar results were observed by Becskei et al . (2023), who evaluated the use of sarolaner in combination, also with two monthly doses, achieving 99.2% reduction on day 60 in a smaller-scale study and 100% parasitological cure in the same period in a larger-scale study. The need for multiple administrations for sarolaner, as evidenced in both this study and the literature, reinforces the advantage of WellPet™ regarding the simplicity of the therapeutic protocol, which can favor treatment adherence by owners and clinicians. In the case of otodectic mange, WellPet™ demonstrated 94.11% efficacy as early as day 14, reaching 100% from day 21. Additionally, complete remission of clinical signs associated with the disease, such as head shaking, pruritus, trauma or alopecia, erythema, ulceration, and debris, was also verified. These results suggest a faster clinical response under the conditions evaluated in relation to the results observed with afoxolaner (Carithers, 2016), whose efficacy was 98.5% (geometric mean) and 99.4% (arithmetic mean) only on day 28, reinforcing the potential of fluralaner as an effective alternative in the control of canine otodectic mange. The clinical response observed in this study is also corroborated by Taenzler et al . (2017), who reported a 99.8% reduction in O. cynotis counts on day 28 after a single oral dose of fluralaner, with absence of visible mites on otoscopy as early as day 14 or 28 in most cases. Conclusion The obtained results confirm the high efficacy of WellPet™ (fluralaner administered orally, at a single dose of 10 to 22.5 mg/kg) in the treatment of both sarcoptic and otodectic mange, showing comparable performance to the other isoxazoline registered in Brazil for those same indications at the time of the study. However, in the animals evaluated, WellPet™ (Ourofino Saúde Animal Ltda.) demonstrated the important advantage of complete parasitological cure of sarcoptic mange with a single administration, simplifying the therapeutic protocol and potentially increasing treatment adherence. For otodectic mange, both products proved to be highly effective, with fluralaner showing a rapid clinical response. Thus, the product positions itself as an effective, safe, and convenient therapeutic option for the management of these studied forms of mange. Declarations Acknowledgements The authors would like to thank all the field veterinarians who participated in these studies. Authors’ contributions BCC and IRHG coordinated the study. MBT performed some of the statistical analysis and the interpretation of the results. FNA, MAMB and CDNP supported in the preparation of the manuscript. All authors were involved in the writing and revision of the manuscript. All authors read and approved the final manuscript. Funding The study was funded by Ourofino Saúde Animal Ltda. Availability of data and materials The datasets generated and analyzed during the present study are not publicly available due to confidentially agreements. All original study documentation is archived by the sponsor. Ethics approval and consent to participate The study protocol was in alignment with national and global guidelines, and owners of all dogs were fully advised of all study procedures prior to signing informed consent. The appropriate Animal Use Ethics Committee previously approved both trials. Consent for publication Not applicable. Competing interests BCC, MBT, GAMC, JACEMS, MGMM,CDNP, MAMB, FNA AND IRHG are employees of Ourofino Saúde Animal Ltda. References ARLIAN, L. G.; MORGAN, M. S. A review of Sarcoptes scabiei: past, present and future. Parasites Vectors. 2017;10:297. doi: 10.1186/s13071-017-2234-1 Andrade GM, Marchiori Filho M, Brunini M, Leonelo Neto A, Ré RA, Matos ATS, et al. Efficacy of ivermectin tablets for the treatment of sarcoptic mange in naturally infested dogs. Pesq Vet Bras. 2017;37(4):385–8. Becskei C, Liebenberg J, Fernandes T, Borowski S, D'Hanis L, Mahabir SP. Efficacy of a chewable tablet containing sarolaner, moxidectin, and pyrantel (Simparica Trio®) in the treatment of sarcoptic mange in dogs. Parasites Vectors. 2023;16:xx. (colocar número do artigo se disponível) Berian S, Gupta SK, Sharma V, Bhardwaj RK, Ali S. Prevalence of canine parasitic dermatitis in and around Jammu. Int J Curr Microbiol Appl Sci. 2018;7(8):2420–6. doi: 10.20546/ijcmas.2018.708.24 Brasil. Casa Civil. Subchefia para Assuntos Jurídicos. Medida Provisória nº 2.200-2, de 24 de agosto de 2001. Disponível em: http://planalto.gov.br/ccivil_03/mpv/antigas_2001/2200-2.htm . Acesso em: 13 May 2024. Brasil. Lei Federal nº 11.794, de 8 de outubro de 2008. Brasília: Diário Oficial da União; 2008. Disponível em: http://planalto.gov.br/ccivil_03/ato2007-2010/2008/lei/l11794.htm . Acesso em: 13 May 2024. Brasil. Decreto nº 6.899, de 15 de julho de 2009. Disponível em: http://planalto.gov.br/ccivil_03/_Ato2007-2010/2009/Decreto/D6899.htm . Acesso em: 13 May 2024. Carithers D, Crawford J, de Vos C, Lotriet A, Fourie J. Assessment of afoxolaner efficacy against Otodectes cynotis infestations of dogs. Parasites Vectors. 2016;9:635. Carmona RC. Dermatopatias parasitárias. In: Larsson CE, Lucas RC, editors. Tratado de medicina externa: dermatologia veterinária. 2nd ed. São Paulo: Interbook; 2020. p. 405. Chiummo R, Petersen I, Plehn C, Zschiesche E, Roepke R, Thomas E. Efficacy of orally and topically administered fluralaner (Bravecto®) for treatment of client-owned dogs with sarcoptic mange under field conditions. Parasites Vectors. 2020;13:524. CONCEA. Guia brasileiro de produção, manutenção ou utilização de animais em atividades de ensino ou pesquisa científica. Brasília: Ministério da Ciência, Tecnologia e Inovação; 2023. Disponível em: https://gov.br/mcti/pt-br/composicao/conselhos/concea/arquivos/arquivo/publicacoes-doconcea/guia_concea_1ed_animais-_ensino_ou_pesquisa_2023.pdf . Acesso em: 13 May 2024. MAPA. Portaria nº 35, de 31 de janeiro de 2020. Brasília: Diário Oficial da União; 2020. Disponível em: https://www.gov.br/agricultura/pt-br/acesso-a-informacao/participacao-social/consultas-publicas/documentos/MinutaRegulamentoTcnicoProdutosAntiparasitrios.pdf . Acesso em: 25 Jun 2024. Taenzler J, de Vos C, Roepke RKA, Frénais R, Heckeroth AR. Efficacy of fluralaner against Otodectes cynotis infestations in dogs and cats. Parasites Vectors. 2017;10:30. Papich MG. Fluralaner. In: Papich Handbook of Veterinary Drugs. 5th ed. St. Louis: Elsevier; 2020. p. 387–389. doi: 10.1016/B978-0-323-70957-6.00227-2 Spinosa HS, Górniak SL, Bernardi MM. Farmacologia Aplicada à Medicina Veterinária. 6th ed. Rio de Janeiro: Guanabara Koogan; 2017. Wan N, Nik K, Nik N, Norlida O, Saipul B. A survey of ear mites (Otodectes cynotis) in stray cats in Kota Bharu, Kelantan, West Malaysia. Malays J Vet Res. 2017;8(1):173–6. Wilkinson V, Takano K, Nichols D, Martin A, Holme R, Phalen D, et al. Fluralaner as a novel treatment for sarcoptic mange in the bare-nosed wombat (Vombatus ursinus): safety, pharmacokinetics, efficacy and practicable use. Parasites Vectors. 2021;14:18. Gassel M, Wolf C, Noack S, Williams H, Ilg T. The novel isoxazoline ectoparasiticide fluralaner: selective inhibition of arthropod GABA- and L-glutamate-gated chloride channels and insecticidal/acaricidal activity. Insect Biochem Mol Biol. 2014;45:111–24. doi: 10.1016/j.ibmb.2013.11.009 Additional Declarations Competing interest reported. BCC, MBT, GAMC, JACEMS, MGMM,CDNP, MAMB, FNA AND IRHG are employees of Ourofino Saúde Animal Ltda. 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15:19:35","extension":"html","order_by":32,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":122415,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/4214bd65b5b97ab1eaaa2779.html"},{"id":93246059,"identity":"44419e2f-def6-46f6-8b46-bd6f67ea434e","added_by":"auto","created_at":"2025-10-10 15:11:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":548397,"visible":true,"origin":"","legend":"\u003cp\u003eEfficacy of treatment against\u003cu\u003e \u003c/u\u003e\u003cem\u003eSarcoptes scabiei\u003c/em\u003e with WellPet\u003csup\u003eTM\u003c/sup\u003e or Reference Product (Positive Control Group), during the experimental period.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/c0519fcc7a580bd6813e91e4.png"},{"id":93246061,"identity":"855ce59e-99de-4811-9e79-0638128cba0c","added_by":"auto","created_at":"2025-10-10 15:11:35","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1355545,"visible":true,"origin":"","legend":"\u003cp\u003eRepresentative images showing skin excoriations in an animal (0445) treat with WellPet\u003csup\u003eTM\u003c/sup\u003e at baseline (D-1, left) and the same animal with complete remission of the lesions at D+28 (right).\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/eeacc3be19dc249f58bc0870.png"},{"id":93246814,"identity":"6e6f08ea-91c1-4a80-b094-a50a1e208488","added_by":"auto","created_at":"2025-10-10 15:19:34","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1154092,"visible":true,"origin":"","legend":"\u003cp\u003eRepresentative images showing crusted lesions in an animal (1273) treat with WellPet\u003csup\u003eTM\u003c/sup\u003e at baseline (D-1, left) and the same animal with complete remission of the lesions at D+28 (right).\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/3e8a9b5f5fdaf38ace92eb6a.png"},{"id":93247747,"identity":"62f3b585-2879-4ff6-aaa9-dd384fb84c10","added_by":"auto","created_at":"2025-10-10 15:27:35","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":119832,"visible":true,"origin":"","legend":"\u003cp\u003eEfficacy of treatment against\u003cu\u003e \u003c/u\u003e\u003cem\u003eOtodectes cynotis \u003c/em\u003ewith WellPet\u003csup\u003eTM\u003c/sup\u003e or Reference Product (Positive Control Group), during the experimental period.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/f4fe2459144708eaba265801.png"},{"id":93248455,"identity":"c76eeedc-1b1c-4fe5-be0d-1888e9a5e73a","added_by":"auto","created_at":"2025-10-10 15:35:35","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":109440,"visible":true,"origin":"","legend":"\u003cp\u003eMean mite egg counts (\u003cem\u003eOtodectes cynotis\u003c/em\u003e) of animals medicated with WellPet\u003csup\u003eTM\u003c/sup\u003e (TG) or reference product (CG), during the experimental period.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/8265593a510b0f086eb62851.png"},{"id":103251585,"identity":"4c6bdeb2-f71c-440d-a6a4-b06d4c04e1b1","added_by":"auto","created_at":"2026-02-23 16:10:58","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":5495777,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/7ca048e7-80f6-497f-a2bc-3eba9ddff736.pdf"},{"id":93246068,"identity":"27815a7b-7720-4eac-a13f-6cee42e047ed","added_by":"auto","created_at":"2025-10-10 15:11:35","extension":"tif","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":1075579,"visible":true,"origin":"","legend":"","description":"","filename":"GraphicalAbstract.tif","url":"https://assets-eu.researchsquare.com/files/rs-7658451/v1/4f602d5ad7ea77517d030e3a.tif"}],"financialInterests":"Competing interest reported. BCC, MBT, GAMC, JACEMS, MGMM,CDNP, MAMB, FNA AND IRHG are employees of Ourofino Saúde Animal Ltda.","formattedTitle":"Efficacy of a Fluralaner-based Ectoparasiticide, for the Control of Otodectic and Sarcoptic Mange in Naturally Infested Dogs, Evaluated in Randomized, Double-Blind Clinical Studies","fulltext":[{"header":"Background","content":"\u003cp\u003eParasitic dermatopathies are caused by ectoparasites such as ticks, fleas, and mites, the latter being primarily responsible for clinical cases of mange in domestic animals. The most clinically relevant mites include \u003cem\u003eSarcoptes scabiei\u003c/em\u003e (DE GEER, 1778) and \u003cem\u003eOtodectes cynotis\u003c/em\u003e (HERING, 1838).\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eSarcoptic mange, also known as scabies, is a highly contagious parasitic dermatopathy, affecting a wide variety of mammals, including dogs, cats, production animals, and humans (BERIAN, 2018). Its etiological agent is the mite \u003cem\u003eS. scabiei\u003c/em\u003e, originally described as \u003cem\u003eAcarus scabiei\u003c/em\u003e, which belongs to the subclass \u003cem\u003eAcari\u003c/em\u003e, superorder Acariformes, order Sarcoptiformes, superfamily Sarcoptoidea, family Sarcoptidae (ARLIAN \u0026amp; MORGAN, 2017). \u003cem\u003eS. scabiei\u003c/em\u003e forms, to some extent, species-specific and host-adapted varieties, infecting canids, felids and ungulates, but a variety of other animal groups are also infected (KRAAB\u0026Oslash;L \u003cem\u003eet al.\u003c/em\u003e, 2015).\u003c/p\u003e\u003cp\u003eThis mite does not show a preference for breed, sex, or age (ARLIAN \u0026amp; MORGAN, 2017). The infection causes severe pruritic dermatitis, characterized by hemorrhagic crusts, alopecia, skin thickening, and, in chronic cases, foul odor and lymphadenopathy (ANDRADE \u003cem\u003eet al\u003c/em\u003e., 2017; BORNSTEIN \u003cem\u003eet al\u003c/em\u003e., 2001). The disease tends to manifest more severely in immunosuppressed, malnourished, or vulnerable animals, such as stray dogs or those housed in zoonosis control centers (BARROS \u003cem\u003eet al\u003c/em\u003e., 2019). In addition to its impact on animal welfare, sarcoptic mange can represent a zoonotic risk, especially in contexts of close coexistence between humans and domestic animals. However, it is important to note that \u003cem\u003eS. scabiei\u003c/em\u003e exhibits host specificity, and the variant most commonly found in dogs, \u003cem\u003eS. scabiei var. canis\u003c/em\u003e, is now recognized as being highly adapted to canids (ARLIAN \u0026amp; MORGAN, 2017).\u003c/p\u003e\u003cp\u003eAnother ectoparasite of clinical importance is the mite \u003cem\u003eO. cynotis\u003c/em\u003e, originally described as \u003cem\u003eSarcoptes cynotis\u003c/em\u003e, belonging also to the subclass \u003cem\u003eAcari\u003c/em\u003e, superorder Acariformes, order Sarcoptiformes, superfamily Sarcoptoidea, from the Psoroptidae family, popularly known as the \u0026ldquo;ear mite\u0026rdquo;. It is the etiological agent of otodectic mange, one of the main causes of external otitis in mammals such as dogs and cats (WAN, 2017). These mites predominantly inhabit the surfaces of the ear canal, but may also be found in other regions including the head, paws, and tail tip. Their presence induces intense pruritus and head shaking, which, in more severe cases, can result in lacerations and auricular hematomas. Heavy infestations may predispose animals to secondary fungal and bacterial infections. Clinical signs include bilateral pruritic otitis, presence of dry dark brown cerumen, and self-induced lesions on the ear, face, and neck (CARMONA, 2020).\u003c/p\u003e\u003cp\u003eThe control of sarcoptic and otodectic mange depends on preventive and therapeutic measures. As with all other ectoparasites, the use of chemical compounds, administered orally, topically (spraying, immersion, pour-on, spot-on, impregnated ear tags or collars), or parenterally (subcutaneous), constitutes the basis of their control (ANDREOTTI; KOLLER; GARCIA, 2016). Effective control of mange causing mites should be focused on products that provide sufficient duration of activity to ensure that any eggs hatching subsequent to treatment do not produce viable larvae, and to prevent environmental re-infestation. A systemically acting miticide with a sustained activity is, therefore, an important tool in the treatment and control of mange (CHIUMMO \u003cem\u003eet al.\u003c/em\u003e, 2020).\u003c/p\u003e\u003cp\u003eAmong the available antiparasitics, fluralaner stands out, an isoxazoline with proven efficacy against a wide range of ectoparasites, such as fleas, ticks, dipterans, and mange-causing mites (PAPICH, 2020). Isoxazolines are a chemical class introduced in the 2000s, with three active principles initially approved for veterinary use: afoxolaner, fluralaner, lotilaner, and sarolaner, all of which act as systemic insecticides and acaricides. They are rapidly absorbed and reach peak plasma concentrations within 24 hours, being mainly distributed in tissues such as fat, liver, kidneys, and muscles, and slowly eliminated primarily through feces (SPINOSA \u003cem\u003eet al\u003c/em\u003e., 2017).\u003c/p\u003e\u003cp\u003eAt nanomolar concentrations, fluralaner acts as a potent blocker of ligand-gated chloride channels, mainly GABA-gated (gamma-aminobutyric acid), as well as GLU-gated (glutamate) chloride channels, the former being exclusive to arthropods. This action prevents the influx of chloride ions into the postsynaptic tissue, leading to depolarization, paralysis, and death of the parasite (OZOE \u003cem\u003eet al\u003c/em\u003e., 2010; GASSEL \u003cem\u003eet al\u003c/em\u003e., 2014). In addition to its potency and selectivity, fluralaner has a unique molecular structure compared to other known chloride channel blockers, having a distinct mode of action on the inhibition of the RDL (\u0026ldquo;resistant to dieldrin\u0026rdquo;, one subunit of GABA receptors able to form functional pentameric ligand-gated ion channels, which consists of a long N-terminal extracellular domain and four transmembrane regions, being an important target for various insecticides) subunit of the receptor, with a different binding site in the RDL (ZHOU \u003cem\u003eet al.\u003c/em\u003e, 2025).\u003c/p\u003e\u003cp\u003eFluralaner is widely recognized, in scientific literature, as an adequate alternative for controlling both \u003cem\u003eS. scabiei\u003c/em\u003e and \u003cem\u003eO. cynotis\u003c/em\u003e on a variety of mammals. \u003cem\u003eS. scabiei\u003c/em\u003e is a global threat to wildlife, being documented in more than 200 mammalian species. Infections can be fatal if not treated. At the dosage of 25 to 56 mg/kg, fluralaner was able to control these mites in dogs (both mites), cats (only \u003cem\u003eO. cynotis\u003c/em\u003e), rabbits, maned wolves, raccoon dogs, bare-nosed wombats, koalas and alpacas (only \u003cem\u003eS. scabiei\u003c/em\u003e in all these mammals). However, there are still doubts regarding safety of fluralaner at this dosages, with reported side effects in dogs including vomiting, decreased appetite, diarrhea, lethargy, polydipsia, flatulence, diffuse non-itchy erythematous papules, loss of appetite, pruritis, coughing, mild erythema and mild wheal development (topical use), higher rectal temperatures, lymphedema, pemphigus foliaceus (cutaneous autoimmune disease), and even severe neurological toxicity (difficulty walking and balancing, oral dysphagia, muscle twitching, head and body tremors, myoclonic jerks and generalized ataxia (JIANG \u0026amp; OLD, 2025).\u003c/p\u003e\u003cp\u003eTherefore, evaluating the therapeutic response to fluralaner-based commercial product, at a safer dose range, against major ectoparasites of domestic animals, such as \u003cem\u003eS. scabiei\u003c/em\u003e and \u003cem\u003eO. cynotis\u003c/em\u003e, is a key step toward the proper management of the diseases caused by these mites, and the reduction of its impact on both animal and public health.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eTwo positive-controlled, double blind, randomized, and multicenter clinical trials were conducted to determine the acaricide efficacy of WellPet\u0026trade; (Ourofino Sa\u0026uacute;de Animal Ltda.), a new commercial palatable tablet based on fluralaner, at a dose range of 10 to 22.5 mg/kg, against \u003cem\u003eS. scabiei\u003c/em\u003e and \u003cem\u003eO. cynotis\u003c/em\u003e mites parasitizing naturally infested domestic dogs. Both trials were conducted in accordance with international guidelines for good clinical practices, as established in the Guidance for Industry: Good Clinical Practice (VICH GL9). Furthermore, national regulations regarding the use of animals in scientific research were followed, including Law No. 11,794/2008 (Arouca Law), regulated by Decree No. 6,899/2009, as well as the guidelines of the National Council for the Control of Animal Experimentation (CONCEA), as per the Brazilian Guide for the Production, Maintenance or Use of Animals in Teaching or Scientific Research Activities (2023), especially Chap.\u0026nbsp;14, which deals with studies conducted with domestic animals kept outside teaching or research institutions. The appropriate Animal Use Ethics Committee previously approved both trials.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eAt each study site, activities were distributed between a non-blinded Dispenser, responsible for assigning and administering treatments, but who did not participate in clinical evaluations, and a blinded Examiner, who performed all treatment-related observations.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eCommon points in both studies evaluating the acaricide efficacy of WellPet\u0026trade; against sarcoptic and otodectic mange\u003c/b\u003e\u003c/p\u003e\u003cp\u003eIn each trial, 14 animals were included. To be eligible for inclusion, animals had to be over 12 months of age, weighing more than 2 kg, being microchipped for identification and free from health conditions unrelated to \u003cem\u003eS. scabiei\u003c/em\u003e or \u003cem\u003eO. cynotis\u003c/em\u003e infestations. Additionally, they had to be infested with at least five live mites (for \u003cem\u003eO. cynotis\u003c/em\u003e, animals had to be bilaterally infested with an average of at least five live mites across both ears) and have owner consent confirmed through a signed informed consent form.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eAnimals showing any clinical signs of disease, undergoing medical treatment, having received any medication other than vaccines and anthelmintics within 30 days prior to the start of the study, or being overly aggressive/reactive, would be excluded. All animals were alone in their respective environments, with no contactant animals. During the study, walks, baths, parasite control, contact with animals outside the study, and unauthorized concomitant medications, including anthelmintics, were not permitted.\u003c/p\u003e\u003cp\u003eThe main criterion for evaluating the product's efficacy in each trial was the parasitological cure rate, calculated as the proportion of dogs that showed negative results for \u003cem\u003eS. scabiei\u003c/em\u003e or \u003cem\u003eO. cynotis\u003c/em\u003e. Efficacy was calculated, using the adapted Abbott's formula, at each post-treatment date (CHAV\u0026Eacute;Z, 2016; FOURIE \u003cem\u003eet al.\u003c/em\u003e, 2015):\u003c/p\u003e\u003cp\u003eEfficacy Percentage (%) = {(mean live mite counts in animals on D-1) - (mean live mite counts on D\u0026thinsp;+\u0026thinsp;X) \u0026divide; (mean live mite counts in animals on D-1)} x 100\u003c/p\u003e\u003cp\u003eAt this formula, D\u0026thinsp;+\u0026thinsp;X refers to each of the post-treatment counts. For a product to be considered adequate acaricide, its calculated efficacy must be at least above 90% (MAPA, 2020).\u003c/p\u003e\u003cp\u003eAll data generated in each study were statistically evaluated using Student's t-test (parametric) or Mann-Whitney (non-parametric) for comparisons between groups and between treatment times. Intragroup comparisons were also performed using the paired t-test (parametric) or Wilcoxon test (non-parametric), depending on data distribution. Statistical tests were performed with the aid of both the SPSS program, version 22, developed by IBM (2013) and the Minitab\u0026reg; Statistical Software (\u0026copy; 2025 Minitab, LLC.). Statistical significance would be considered when the p-value was less than 5% (p\\\u0026lt;0.05).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eDetermination of adequate Sample Sizes (\u0026ldquo;N\u0026rdquo;):\u003c/h2\u003e\u003cp\u003eThe Experimental Power Graphing Program spreadsheet was used when designing the protocols. This is a tool which assists in determining the power of a test and consequently defining the appropriate number of repetitions, as part of the programs made available by the University of Georgia, in Bulletin 1491 of its extension publications (Three Workbooks to Help Estimate Experimental Power and Normalize Experimental Data), to estimate the experimental power of a study and normalize experimental data (PESTI \u003cem\u003eet al\u003c/em\u003e., 2018). Counts of animals parasitized by Sarcoptoidea mites, in previous recent studies conducted by the same researchers, were selected. The mean data from these counts (average of 11 mites per animal, with a standard deviation of 4,0) were corroborated by data from published literature studies evaluating efficacy against mites (TAENZLER \u003cem\u003eet al\u003c/em\u003e., 2016; CHIUMMO \u003cem\u003eet al\u003c/em\u003e., 2020). Mean and standard deviation data were used without applying any transformation, which already met the normality assumption in the distribution. In the program, the specific tab for data with a constant coefficient of variation (CV) was used, as the standard deviations of mite counts vary proportionally to the mean values observed at each time point. This approach generally indicates the need for a larger number of units to achieve the desired experimental power, with the estimate considered more conservative. As a confidence level, 0.05 (α\u0026thinsp;=\u0026thinsp;0.05, i.e., 95% confidence interval) was considered, and 0.8 (1-β\u0026thinsp;=\u0026thinsp;80%) as the desired power for the test. With these data, the power of the test was then calculated for each different hypothesis (percentage of mite reduction at each post-treatment time point, compared to the initial means of the respective groups) and for various numbers of repetitions (simulated numbers of dogs per experimental group) as shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePower of the test calculated for each hypothesis (percentage of difference between mite counts and distinct potential number of repetitions evaluated), considering a confidence level of 0.05 (α\u0026thinsp;=\u0026thinsp;0.05, i.e., 95% confidence interval) and 0.8 (1-β\u0026thinsp;=\u0026thinsp;80%) as the minimum acceptable power for the test.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"11\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003ePercent difference\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"10\" nameend=\"c11\" namest=\"c2\"\u003e\u003cp\u003eSample size (n per group)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c11\"\u003e\u003cp\u003e11\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-50%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.075\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.281\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.506\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.666\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.775\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.848\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.898\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.932\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.955\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.970\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-55%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.084\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.362\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.618\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.771\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.862\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.917\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.950\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.970\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.982\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.989\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-60%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.095\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.457\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.721\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.853\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.921\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.957\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.977\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.988\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.993\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.996\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-65%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.109\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.557\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.806\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.910\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.957\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.979\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.990\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.995\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.998\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-70%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.126\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.653\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.870\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.947\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.978\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.990\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.996\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.998\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-75%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.149\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.737\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.915\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.969\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.988\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.996\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.998\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-80%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.178\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.806\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.945\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.982\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.994\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.998\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-85%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.214\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.858\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.964\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.990\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.997\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e-90%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.257\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.896\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.976\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.994\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.998\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e0.999\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e\u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e1.000\u003c/span\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe simulation results indicated that a minimum of seven (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) repetitions per group was sufficient to detect differences in mite quantification (efficacy) of 50% or greater as statistically significant, with a confidence level exceeding 95%. Thus, a minimum of seven animals per group was considered fully adequate for the execution of the present assays, in accordance with all reference guidelines. This sample size ensured the statistical robustness of the experimental model while adhering to the principle of using the 'minimum number of necessary animals'\u003c/p\u003e\u003cp\u003eAdditionally, the sample size of seven animals per group is consistent with previously published efficacy studies for mange treatments in dogs, which frequently utilize samples of similar or slightly larger size to demonstrate significant results. For instance, studies such as Andrade \u003cem\u003eet al\u003c/em\u003e. (2017), Carithers \u003cem\u003eet al\u003c/em\u003e. (2016), and Taenzler \u003cem\u003eet al\u003c/em\u003e. (2016) employed a comparable number of animals per group to evaluate the efficacy of different treatments for parasitic infestations.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy 1: Evaluation of the acaricide efficacy of WellPet\u003c/b\u003e \u003csup\u003e\u003cb\u003eTM\u003c/b\u003e\u003c/sup\u003e \u003cb\u003efor the control of sarcoptic mange in dogs naturally infested by\u003c/b\u003e \u003cb\u003eSarcoptes scabiei\u003c/b\u003e\u003c/p\u003e\u003cp\u003e14 animals were included in the study, comprising 42.9% males (6/14) and 57.1% females (8/14), with a mean age of 4.7 years (animals aged 1 to 9 years).\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe 14 animals were divided into two groups: the Treated Group (n\u0026thinsp;=\u0026thinsp;seven) and the Positive Control Group (n\u0026thinsp;=\u0026thinsp;seven). Animals in the Treated Group received WellPet\u0026trade; (Ourofino Sa\u0026uacute;de Animal Ltda.) orally on Day 0 (D0), at the dose recommended in the package insert, which provides a minimum of 10 mg/kg of fluralaner. Animals in the Positive Control Group received a reference oral antiparasitic product containing at the recommended dose, corresponding to a minimum of 2 mg/kg of fluralaner.\u003c/p\u003e\u003cp\u003eOn days\u0026thinsp;+\u0026thinsp;3, +7, +\u0026thinsp;14, +21, +\u0026thinsp;28 after treatment, clinical evaluations, acaricide efficacy evaluations, and dermatological evaluations were performed. If mites were still present on Day 28 (D\u0026thinsp;+\u0026thinsp;28) - i.e., if the final post-treatment assessment revealed at least one live mite - a second treatment was administered on Day 30 (D\u0026thinsp;+\u0026thinsp;30), in accordance with the monthly dosing schedule recommended for both WellPet\u0026trade; and the reference product. Following the second treatment, if and when needed, new evaluations were conducted, on Days\u0026thinsp;+\u0026thinsp;33, +37, +\u0026thinsp;44, +51, and +\u0026thinsp;58.\u003c/p\u003e\u003cp\u003eTo evaluate acaricidal efficacy, at each moment, mites were collected and counted via skin scrapings from five areas of each animal. At least 2.5 cm\u0026sup2; (\u0026asymp;\u0026thinsp;0.39 sq in) of skin showing evidence of active mite infestation was scraped until capillary bleeding occurred. A veterinarian, blinded to the treatment group, performed the parasitological examination, quantifying adult and immature \u003cem\u003eS. scabiei\u003c/em\u003e mites under 10\u0026times; magnification. Dermatological assessment of lesion severity was conducted prior to sample collection in two areas, based on the following parameters: pruritus, erythema, papules, excoriations, crusts, alopecia, and pyoderma.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy 2: Evaluation of the acaricide efficacy of WellPet\u0026trade; for the control of sarcoptic mange in dogs naturally infested by\u003c/b\u003e \u003cb\u003eOtodectes cynotis\u003c/b\u003e\u003c/p\u003e\u003cp\u003eAnother 14 animals were included in this study, comprising once again 42.9% males (6/14) and 57.1% females (8/14), with a mean age of 4.7 years (animals aged 1 to 10 years).\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe 14 animals were also divided into two groups: Treated Group (n\u0026thinsp;=\u0026thinsp;seven) and Positive Control Group (n\u0026thinsp;=\u0026thinsp;seven), using the same products and doses as in Study 1. Clinical evaluations, acaricide efficacy evaluations, and dermatological evaluations of skin lesions also followed the same criteria and evaluation days as the first trial. However, for the evaluation of skin lesions, indirect assessments were conducted to identify the presence or absence of clinical signs associated with otodectic mange, such as head shaking, pruritus, trauma or alopecia, erythema, ulceration, and debris, among others.\u003c/p\u003e\u003cp\u003eTo evaluate acaricidal efficacy, each count was preceded by the collection of material from both ear canals (right and left), as well as skin scrapings of the external and middle ear (approximately 1 cm\u0026sup2; [\u0026asymp;\u0026thinsp;0.16 sq in]). Evaluations of the left and right sides were performed separately to ensure bilateral infestation. The total number of live mites from both sides was considered the final count for each animal. Additionally, in all evaluations, the number of \u003cem\u003eO. cynotis\u003c/em\u003e eggs present was also recorded. For the collection of material from the ear canals, a swab was used to gently remove debris. Mite and egg counts were recorded per slide, and subsequently, the arithmetic and geometric means were calculated for each animal. For microscopic examination, the material collected from each side (ear canal and scraping) was spread on a slide and analyzed to detect mites and eggs.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eConfirmation of adequacy of Sample Sizes (\u0026ldquo;N\u0026rdquo;):\u003c/h2\u003e\u003cp\u003eAfter the studies were finished, pre-treatment data was compiled and calculations using the Experimental Power Graphing Program spreadsheet (PESTI \u003cem\u003eet al\u003c/em\u003e., 2018) were repeated with the real data obtained on each trial (average of 12.86 \u003cem\u003eS. scabiei\u003c/em\u003e mites before treatment, with a standard deviation of 3.63; and average of 17.14 \u003cem\u003eO. cynotis\u003c/em\u003e mites before treatment, with a standard deviation of 6.74). With a confidence level of 0.05 and a desired power of 0.8, a minimum of seven repetitions per group was confirmed as sufficient to detect differences in mite quantification (inferiority in \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003eefficacy\u003c/span\u003e indexes) of 50% or greater as statistically significant (for \u003cem\u003eO. cynotis\u003c/em\u003e, differences of 40% or greater would be identified as statistically significant).\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy 1 -\u003c/b\u003e \u003cb\u003eSarcoptes scabiei\u003c/b\u003e:\u003c/p\u003e\u003cp\u003eRegarding the clinical condition of animals, the occurrence of abnormal clinical signs was observed. However, these were only changes resulting from verminosis or stress of the animals at the time of clinical evaluations. Some animals presented Grade 2 (mild) dehydration (3 to 4 seconds), regarding capillary refill time (CRT). However, by the end of the study, these returned to normality. Additionally, all animals exhibited normal behavior throughout the whole trial.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eAfter the first negative result for each animal\u0026rsquo;s Acari counts, confirmation was obtained through additional skin scrapings, performed at weekly day intervals, totaling three consecutive negative results. At the end of the 30-day evaluation period, after the first treatments, two animals in the Control Group still tested positive for mites, requiring a second sarolaner administration. No animals treated with WellPet\u0026trade; needed a second fluralaner administration. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e01\u003c/span\u003e presents the mean mite counts for each group at each experimental time point.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eStatistical analysis of the total mite counts per animal (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) revealed distinct intragroup trends. The Control group showed a statistically significant reduction in mite counts from Day 7 (p\u0026thinsp;=\u0026thinsp;0,045) onwards, while the WellPet\u003csup\u003eTM\u003c/sup\u003e-treated group reached statistical significance starting from Day 14 (p\u0026thinsp;=\u0026thinsp;0,022). Nonetheless, WellPet\u0026trade; achieved full 100% efficacy by Day 28, without the need for re-treatment. The Control Group, however, required re-treatment for two animals to reach 100% efficacy by Day 44. Intergroup comparison showed no statistically significant differences (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). These results confirm WellPet\u0026trade;'s effectiveness, surpassing the minimum threshold of 90% efficacy (MAPA, 2020), completely controlling \u003cem\u003eS. scabiei\u003c/em\u003e infestations four weeks after a single administration.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eScabicidal efficacy results (Mite Count) against \u003cem\u003eS. scabiei\u003c/em\u003e and Intragroup and Intergroup Statistical Analyses of Treated Groups.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"9\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eTime point (Day)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003eGroup 1 \u0026ndash; WellPet\u0026trade; (single oral dose of fluralaner \u0026ndash; 10 to 22.5 mg/kg)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cp\u003eGroup 2 \u0026ndash; Control (single oral dose of sarolaner, repeated after 30 days if necessary)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e\u003cp\u003eIntergroup p-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eEfficacy percentages\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eIntragroup (\u003cem\u003evs\u003c/em\u003e day \u0026minus;\u0026thinsp;1) p-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eEfficacy percentages\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eIntragroup (\u003cem\u003evs\u003c/em\u003e day \u0026minus;\u0026thinsp;1) p-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003eGroup comparison\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD-1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14.00\u0026thinsp;\u0026plusmn;\u0026thinsp;6.24 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e12.86\u0026thinsp;\u0026plusmn;\u0026thinsp;3.63 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.683\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11.71\u0026thinsp;\u0026plusmn;\u0026thinsp;8.06 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e16.3%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.152\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e8.86\u0026thinsp;\u0026plusmn;\u0026thinsp;6.01 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e36.7%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.103\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.467\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7.57\u0026thinsp;\u0026plusmn;\u0026thinsp;8.10 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e45.9%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.082*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6.29\u0026thinsp;\u0026plusmn;\u0026thinsp;6.87 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e51.1%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.045*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.754\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.14\u0026thinsp;\u0026plusmn;\u0026thinsp;4.71 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e77.5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.00\u0026thinsp;\u0026plusmn;\u0026thinsp;3.06 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e76.7%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.003*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.947\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.29\u0026thinsp;\u0026plusmn;\u0026thinsp;0.76 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e81.6%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.43\u0026thinsp;\u0026plusmn;\u0026thinsp;2.44 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e88.9%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.259\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.71\u0026thinsp;\u0026plusmn;\u0026thinsp;2.98 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e86.7%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.154\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.75\u0026thinsp;\u0026plusmn;\u0026thinsp;3.20 (n\u0026thinsp;=\u0026thinsp;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e91.1%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.01*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.149\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;51\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"9\"\u003eLegend: * Statistically significant; \u003csup\u003ea\u003c/sup\u003eNot enough data to assess normality; statistical analysis not applicable.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eIn the evaluation of skin lesions resulting from sarcoptic mange, no statistically significant differences were observed between the groups for any of the analyzed variables throughout the study.\u003c/p\u003e\u003cp\u003eFrom D\u0026thinsp;+\u0026thinsp;28 onwards, pruritus was completely absent in animals treated with WellPet\u0026trade;. In contrast, animals in the Control Group only achieved total absence of pruritus by D\u0026thinsp;+\u0026thinsp;37. Similarly, erythema resolved entirely in the Treated Group by D\u0026thinsp;+\u0026thinsp;14 and remained absent until the end of the study, whereas in the Control Group, complete resolution was only observed starting from D\u0026thinsp;+\u0026thinsp;28. Excoriations disappeared entirely in the Treated Group as early as D\u0026thinsp;+\u0026thinsp;14 (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e02\u003c/span\u003e), while in the Control Group, this occurred only by D\u0026thinsp;+\u0026thinsp;21. In both cases, erythema was not detectable anymore even before total elimination of \u003cem\u003eS. scabiei\u003c/em\u003e infestations. Regarding crusted lesions (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e03\u003c/span\u003e), total resolution was observed on D\u0026thinsp;+\u0026thinsp;14 in the Treated Group and even earlier in the Control Group, on D\u0026thinsp;+\u0026thinsp;7. Finally, alopecia was completely resolved in the Treated Group by D\u0026thinsp;+\u0026thinsp;37, while in the Control Group, full recovery was only observed at the end of the study, on D\u0026thinsp;+\u0026thinsp;58. For alopecia, as expected, complete resolution only happened after total elimination of Acari infestations.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy 2 -\u003c/b\u003e \u003cb\u003eOtodectes cynotis\u003c/b\u003e:\u003c/p\u003e\u003cp\u003eRegarding the clinical picture, only the occurrence of abnormal clinical signs related to a positive diagnosis for \u003cem\u003eO. cynotis\u003c/em\u003e were observed.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eAt the end of the thirty (30) days of evaluation, after treatment of animals with single dosages of each product, all animals in both groups showed negative results for mites, confirmed in at least three consecutive negative collections. Therefore, no second treatment was required for any animal. A small number of animals from each group still had mites detected on D\u0026thinsp;+\u0026thinsp;14, and only began to show complete negativity from D\u0026thinsp;+\u0026thinsp;21 \u0026mdash; specifically, two dogs in the Treated Group and three in the Control Group. For these animals, an additional evaluation on D\u0026thinsp;+\u0026thinsp;33 was necessary to complete the three required negative assessments. WellPet\u0026trade; demonstrated 94,1% efficacy as early as day 14, reaching 100% from day 21. Figure\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e04\u003c/span\u003e presents the means mite counts for each group at each experimental time point.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eUpon analyzing the mite count data, which represents the final average count from the right and left ears, statistical results are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. In the intragroup analysis, the Treated group demonstrated a statistically significant reduction in mite counts compared to baseline as early as Day 3 post-treatment (p\u0026thinsp;=\u0026thinsp;0,036). The Control group, in turn, achieved a statistically significant reduction from Day 7 (p\u0026thinsp;=\u0026thinsp;0,022) onwards. Though the Control group achieved 100% efficacy first, by Day 14, in the intergroup analysis, no statistically significant differences were observed between the groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Furthermore, egg count data, presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e05\u003c/span\u003e, also showed no statistically significant differences between the groups. As this parameter served only as a complementary factor for the efficacy assessment, and not as a primary outcome variable, intragroup analysis was not performed.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eScabicidal efficacy results (Mite Count) against \u003cem\u003eO. cynotis\u003c/em\u003e and Intragroup and Intergroup Statistical Analyses of Treated Groups\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"8\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eTime point (Day)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003eGroup 1 \u0026ndash; WellPet\u0026trade; (single oral dose of fluralaner \u0026ndash; 10 to 22.5 mg/kg)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e\u003cp\u003eGroup 2 \u0026ndash; Control (single oral dose of sarolaner, repeated after 30 days if necessary)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eIntergroup p-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eEfficacy percentages\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eIntragroup (\u003cem\u003evs\u003c/em\u003e day \u0026minus;\u0026thinsp;1) p-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD (N)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eEfficacy percentages\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eIntragroup (\u003cem\u003evs\u003c/em\u003e day \u0026minus;\u0026thinsp;1) p-value\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eGroup comparison\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD-1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17.14\u0026thinsp;\u0026plusmn;\u0026thinsp;6.74 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e13.00\u0026thinsp;\u0026plusmn;\u0026thinsp;8.10 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,319\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.43\u0026thinsp;\u0026plusmn;\u0026thinsp;7.02 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e29,4%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,036*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e7.71\u0026thinsp;\u0026plusmn;\u0026thinsp;2.93 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e38,5%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,053\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,127\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.38\u0026thinsp;\u0026plusmn;\u0026thinsp;3.53 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e70,6%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,001*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.86\u0026thinsp;\u0026plusmn;\u0026thinsp;1.21 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e76,9%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,182\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.41 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e94,1%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.29\u0026thinsp;\u0026plusmn;\u0026thinsp;0.49 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,022*\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0,23\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eD\u0026thinsp;+\u0026thinsp;33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00 (n\u0026thinsp;=\u0026thinsp;2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e100%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e-\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"8\"\u003eLegend: * Statistically significant; \u003csup\u003ea\u003c/sup\u003eNot enough data to assess normality; statistical analysis not applicable.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eIn the evaluation of skin lesions resulting from otodectic mange, there was no statistical difference for any of the analyzed variables. However, it is worth noting that, despite the resolution of other dermatological signs by the end of the study, some animals in both groups still exhibited mild alopecia. The persistence of alopecia in these two animals is likely due to the fact that hair regrowth is a dermatological process that requires a longer recovery period.\u003c/p\u003e\u003cp\u003eIt is also noteworthy that, from D\u0026thinsp;+\u0026thinsp;7, erythema was already completely absent in the group treated with WellPet\u0026trade;, whereas in the Control Group, this was only observed from D\u0026thinsp;+\u0026thinsp;14. Both treatments achieved 100% acaricidal efficacy with a single application, as evidenced by the complete elimination of mites confirmed through consecutive weekly counts, along with full remission of clinical signs associated with otodectic mange (Fig.\u0026nbsp;06).\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn the treatment of sarcoptic mange, WellPet\u0026trade; demonstrated high efficacy in the animals evaluated in this study, achieving 100% parasitological control 28 days after all animals were treated with a single administration of this product, in a dose of 10 to 22.5 mg/kg of fluralaner. Furthermore, complete remission of associated clinical signs, such as pyoderma, pruritus, erythema, excoriations, crusts, and alopecia, was observed, with no animal in the study requiring readministration until the end of the follow-up period (D\u0026thinsp;+\u0026thinsp;58). Although no statistically significant differences were observed compared to the Control Group, the latter only achieved complete efficacy after the second administration, demonstrating a practical advantage of WellPet\u0026trade; in terms of therapeutic convenience.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe findings are consistent with the literature. Taenzler \u003cem\u003eet al\u003c/em\u003e. (2016) demonstrated that a single dose of fluralaner, administered orally or topically, resulted in 100% reduction in \u003cem\u003eS. scabiei\u003c/em\u003e counts after four weeks. Similarly, Chiummo \u003cem\u003eet al.\u003c/em\u003e (2020) reported that over 90% of dogs were mite-free on day 28, with 100% efficacy on days 56 and 84, lasting up to 12 weeks. In the same study, the control group treated with sarolaner required two administrations (days 0 and 28) to achieve complete mite elimination on days 56 and 84 \u0026mdash; a treatment approach that was also necessary in the present study to ensure full resolution in some animals.\u003c/p\u003e\u003cp\u003eSimilar results were observed by Becskei \u003cem\u003eet al\u003c/em\u003e. (2023), who evaluated the use of sarolaner in combination, also with two monthly doses, achieving 99.2% reduction on day 60 in a smaller-scale study and 100% parasitological cure in the same period in a larger-scale study. The need for multiple administrations for sarolaner, as evidenced in both this study and the literature, reinforces the advantage of WellPet\u0026trade; regarding the simplicity of the therapeutic protocol, which can favor treatment adherence by owners and clinicians.\u003c/p\u003e\u003cp\u003eIn the case of otodectic mange, WellPet\u0026trade; demonstrated 94.11% efficacy as early as day 14, reaching 100% from day 21. Additionally, complete remission of clinical signs associated with the disease, such as head shaking, pruritus, trauma or alopecia, erythema, ulceration, and debris, was also verified.\u003c/p\u003e\u003cp\u003eThese results suggest a faster clinical response under the conditions evaluated in relation to the results observed with afoxolaner (Carithers, 2016), whose efficacy was 98.5% (geometric mean) and 99.4% (arithmetic mean) only on day 28, reinforcing the potential of fluralaner as an effective alternative in the control of canine otodectic mange. The clinical response observed in this study is also corroborated by Taenzler \u003cem\u003eet al\u003c/em\u003e. (2017), who reported a 99.8% reduction in \u003cem\u003eO. cynotis\u003c/em\u003e counts on day 28 after a single oral dose of fluralaner, with absence of visible mites on otoscopy as early as day 14 or 28 in most cases.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe obtained results confirm the high efficacy of WellPet\u0026trade; (fluralaner administered orally, at a single dose of 10 to 22.5 mg/kg) in the treatment of both sarcoptic and otodectic mange, showing comparable performance to the other isoxazoline registered in Brazil for those same indications at the time of the study. However, in the animals evaluated, WellPet\u0026trade; (Ourofino Sa\u0026uacute;de Animal Ltda.) demonstrated the important advantage of complete parasitological cure of sarcoptic mange with a single administration, simplifying the therapeutic protocol and potentially increasing treatment adherence. For otodectic mange, both products proved to be highly effective, with fluralaner showing a rapid clinical response. Thus, the product positions itself as an effective, safe, and convenient therapeutic option for the management of these studied forms of mange.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank all the field veterinarians who participated in these studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBCC and IRHG coordinated the study. MBT performed some of the statistical analysis and the interpretation of the results. FNA, MAMB and CDNP supported in the preparation of the manuscript. All authors were involved in the writing and revision of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was funded by Ourofino Sa\u0026uacute;de Animal Ltda.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the present study are not publicly available due to confidentially agreements. All original study documentation is archived by the sponsor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was in alignment with national and global guidelines, and owners of all dogs were fully advised of all study procedures prior to signing informed consent. The appropriate Animal Use Ethics Committee previously approved both trials.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBCC, MBT, GAMC, JACEMS, MGMM,CDNP, MAMB, FNA AND IRHG are employees of Ourofino Sa\u0026uacute;de Animal Ltda.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eARLIAN, L. G.; MORGAN, M. S. A review of Sarcoptes scabiei: past, present and future. Parasites Vectors. 2017;10:297. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s13071-017-2234-1\u003c/span\u003e\u003cspan address=\"10.1186/s13071-017-2234-1\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAndrade GM, Marchiori Filho M, Brunini M, Leonelo Neto A, R\u0026eacute; RA, Matos ATS, et al. Efficacy of ivermectin tablets for the treatment of sarcoptic mange in naturally infested dogs. Pesq Vet Bras. 2017;37(4):385\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBecskei C, Liebenberg J, Fernandes T, Borowski S, D'Hanis L, Mahabir SP. Efficacy of a chewable tablet containing sarolaner, moxidectin, and pyrantel (Simparica Trio\u0026reg;) in the treatment of sarcoptic mange in dogs. 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S\u0026atilde;o Paulo: Interbook; 2020. p. 405.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChiummo R, Petersen I, Plehn C, Zschiesche E, Roepke R, Thomas E. Efficacy of orally and topically administered fluralaner (Bravecto\u0026reg;) for treatment of client-owned dogs with sarcoptic mange under field conditions. Parasites Vectors. 2020;13:524.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCONCEA. Guia brasileiro de produ\u0026ccedil;\u0026atilde;o, manuten\u0026ccedil;\u0026atilde;o ou utiliza\u0026ccedil;\u0026atilde;o de animais em atividades de ensino ou pesquisa cient\u0026iacute;fica. Bras\u0026iacute;lia: Minist\u0026eacute;rio da Ci\u0026ecirc;ncia, Tecnologia e Inova\u0026ccedil;\u0026atilde;o; 2023. 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St. Louis: Elsevier; 2020. p. 387\u0026ndash;389. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/B978-0-323-70957-6.00227-2\u003c/span\u003e\u003cspan address=\"10.1016/B978-0-323-70957-6.00227-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSpinosa HS, G\u0026oacute;rniak SL, Bernardi MM. Farmacologia Aplicada \u0026agrave; Medicina Veterin\u0026aacute;ria. 6th ed. Rio de Janeiro: Guanabara Koogan; 2017.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWan N, Nik K, Nik N, Norlida O, Saipul B. A survey of ear mites (Otodectes cynotis) in stray cats in Kota Bharu, Kelantan, West Malaysia. Malays J Vet Res. 2017;8(1):173\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWilkinson V, Takano K, Nichols D, Martin A, Holme R, Phalen D, et al. Fluralaner as a novel treatment for sarcoptic mange in the bare-nosed wombat (Vombatus ursinus): safety, pharmacokinetics, efficacy and practicable use. Parasites Vectors. 2021;14:18.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGassel M, Wolf C, Noack S, Williams H, Ilg T. The novel isoxazoline ectoparasiticide fluralaner: selective inhibition of arthropod GABA- and L-glutamate-gated chloride channels and insecticidal/acaricidal activity. Insect Biochem Mol Biol. 2014;45:111\u0026ndash;24. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ibmb.2013.11.009\u003c/span\u003e\u003cspan address=\"10.1016/j.ibmb.2013.11.009\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"parasites-and-vectors","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"parv","sideBox":"Learn more about [Parasites \u0026 Vectors](http://parasitesandvectors.biomedcentral.com/)","snPcode":"13071","submissionUrl":"https://submission.nature.com/new-submission/13071/3","title":"Parasites \u0026 Vectors","twitterHandle":"@bugbittentweets","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Acaricide, Isoxazoline, Mites, Otodectes cynotis, Sarcoptes scabiei, Treatment","lastPublishedDoi":"10.21203/rs.3.rs-7658451/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7658451/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eParasitic dermatopathies account for approximately 30% of cases in veterinary clinics, primarily caused by ticks, fleas, and mites. Parasitic mites cause mange, a term used to describe a type of skin disease. One of the most relevant parasitic Acari is \u003cem\u003eSarcoptes scabiei\u003c/em\u003e, which causes sarcoptic mange, mainly called scabies in humans. This condition is highly contagious, affects various mammals and humans, leading to intense itching and skin lesions. Another significant mite is \u003cem\u003eOtodectes cynotis\u003c/em\u003e, the \"ear mite\", which is the primary cause of external otitis in mammals, causing severe ear itching. The treatment and control of these forms of mange rely on the use of antiparasitics, such as fluralaner, which acts by paralyzing and killing the parasites.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eTwo clinical studies were conducted to evaluate the acaricide efficacy against these mites. Both studies utilized 14 animals each, divided into a Control Group (n\u0026thinsp;=\u0026thinsp;7), treated with a reference product based on sarolaner, and a Treated Group (n\u0026thinsp;=\u0026thinsp;7) treated with WellPet\u0026trade; (a palatable tablet based on fluralaner, 10 to 22.5 mg/kg \u0026ndash; Ourofino Sa\u0026uacute;de Animal Ltda.). Acaricide efficacy was assessed through mite counts and evaluation of lesions resulting from the diseases.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThere was no statistical difference in the comparison between the Treated and Control groups in either trial. WellPet\u0026trade; demonstrated 100% efficacy against sarcoptic mange after a single administration, unlike the reference product, which required two monthly administrations. For otodectic mange, both products reached adequate efficacy after a single use.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eThe WellPet\u0026trade; product, a novel ectoparasiticide based on fluralaner, proved to be highly effective in the treatment of both sarcoptic and otodectic mange, with results similar to those of sarolaner. The main advantage of WellPet\u0026trade; is the ability to achieve complete cure of sarcoptic mange with a single dose, thereby simplifying disease management. For otodectic mange, both products were highly effective. In summary, WellPet\u0026trade; is an effective and practical treatment option for these types of mange.\u003c/p\u003e","manuscriptTitle":"Efficacy of a Fluralaner-based Ectoparasiticide, for the Control of Otodectic and Sarcoptic Mange in Naturally Infested Dogs, Evaluated in Randomized, Double-Blind Clinical Studies","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-10 15:11:30","doi":"10.21203/rs.3.rs-7658451/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-10-27T17:30:24+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-27T16:33:12+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-27T06:26:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"122094895798716093337558865111988844367","date":"2025-10-06T14:02:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"70889944929911213886730952217052618430","date":"2025-10-05T17:13:05+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-27T17:27:06+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-20T11:11:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-20T10:52:34+00:00","index":"","fulltext":""},{"type":"submitted","content":"Parasites \u0026 Vectors","date":"2025-09-19T12:06:20+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"parasites-and-vectors","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"parv","sideBox":"Learn more about [Parasites \u0026 Vectors](http://parasitesandvectors.biomedcentral.com/)","snPcode":"13071","submissionUrl":"https://submission.nature.com/new-submission/13071/3","title":"Parasites \u0026 Vectors","twitterHandle":"@bugbittentweets","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5cd12fd6-e0a5-4738-bdd1-b1c188eba6ed","owner":[],"postedDate":"October 10th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-02-23T16:07:14+00:00","versionOfRecord":{"articleIdentity":"rs-7658451","link":"https://doi.org/10.1186/s13071-026-07279-3","journal":{"identity":"parasites-and-vectors","isVorOnly":false,"title":"Parasites \u0026 Vectors"},"publishedOn":"2026-02-22 15:58:55","publishedOnDateReadable":"February 22nd, 2026"},"versionCreatedAt":"2025-10-10 15:11:30","video":"","vorDoi":"10.1186/s13071-026-07279-3","vorDoiUrl":"https://doi.org/10.1186/s13071-026-07279-3","workflowStages":[]},"version":"v1","identity":"rs-7658451","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7658451","identity":"rs-7658451","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}