Effect of a standardised Ophytrium‐containing shampoo and a leave‐on mousse protocol on dogs with irritated and pruritic skin

Abstract

Objectives

Topical formulations are helpful and versatile management modalities for skin disorders. However, veterinary studies assessing their efficacies are limited. This study evaluated the effects of a protocol comprising the combined application of an Ophytrium‐based shampoo and a leave‐on mousse (DOUXO^® S3 CALM range) on dogs with irritated and pruritic skin.

Materials and Methods

A multicentre, open‐label, uncontrolled trial  was conducted at 12 veterinary clinics in France, Spain and the United States. Included dogs underwent shampoo application on Day 0 (D0), followed by eight sessions of mousse application at 2‐ to 3‐day intervals. Canine Atopic Dermatitis Extent and Severity Index‐4 (CADESI‐04) scores assessed by veterinarians and pruritus visual analogue scale (PVAS) scores reported by owners were evaluated weekly.

Results

Thirty‐four dogs with atopy were included. The mean CADESI‐04 score decreased significantly from 24.2 on D0 to 11.9 on Day 21 (D21), with 61.8% of the dogs achieving ≥50 decrease in their CADESI‐04 scores by D21. Additionally, the mean PVAS score decreased significantly from 5.3 on D0 to 3.6 on D21, with 44.1% of the dogs exhibiting ≥50% decrease in their PVAS scores by D21. Veterinarians considered the improvements to be satisfactory, good or excellent in 66.7% of cases. Pet owners were satisfied with the performance of the protocol in 72.7% of cases.

Clinical significance

The standardized topical protocol described herein, when used alone or as an adjuvant treatment to systemic therapy, significantly improved both CADESI‐04 scores and pruritus in atopic dogs presenting with skin flares and mild‐to‐moderate intensity skin lesions.

INTRODUCTION

Canine atopic dermatitis (CAD), a hereditary, generally pruritic and predominantly T‐cell‐driven inflammatory skin disease, involves interplays between skin barrier abnormalities, allergen sensitization and microbial dysbiosis (Santoro et al., 2024), as well as the action of immunoglobulin E (IgE) against environmental allergens (Hensel et al., 2015). Pruritus is the primary clinical sign of CAD. During the first stages, pruritus may not be associated with any lesions (Hensel et al., 2015); however, inflammation, erythema, excoriation, erosion and self‐induced alopecia (Favrot, 2015; Griffin & DeBoer, 2001) may manifest according to severity, and lichenification with hyperpigmentation (Hensel et al., 2015; Olivry & Banovic, 2019) develop with chronicity. The pathogenesis of CAD is not fully understood; nonetheless, there is evidence regarding changes in the mechanical (Marsella et al., 2011; Olivry, 2011) and immunological skin barriers, with an increase in Th2‐mediated cytokine release (Olivry et al., 1999; Schlotter et al., 2011), as well as changes in the microbiological skin barrier, with a lower diversity of both bacteria and fungi (Bradley et al., 2016; Meason‐Smith et al., 2015; Rodrigues Hoffmann et al., 2014) and an increase in the relative abundance of the Staphylococcus genus and Malassezia pachydermatis. This dysbiosis is likely to favour and enhance the intensity of atopic flares. The current International Committee for Allergic Diseases in Animals (ICADA) guidelines and 2019 recommendations for the treatment of CAD emphasize the need for multimodal approaches, including allergen avoidance, use of topical products, use of systemic drugs to reduce pruritus and skin lesions, and allergen‐specific immunotherapy (Olivry et al., 2015; Olivry & Banovic, 2019). The use of nonsteroidal topical agents that contribute to improving skin barrier function and soothing irritation with limited side effects may be beneficial for atopic flares (Bensignor et al., 2013; Bensignor & Fabriès, 2018; Bourdeau et al., 2007; Gatellet et al., 2019) and provide proactive measures to limit and delay relapses. In the ICADA treatment guidelines, only two emollient formulations—one comprising lipids, complex sugars and antiseptic agents (Allermyl®) and another comprising raspberry oil and lipids (DOUXO® Calm range)—are recommended for the treatment of acute flares (Olivry et al., 2010, 2015), with a recommendation strength of B (Ebell et al., 2004). A small randomized controlled trial spanning 3 weeks conducted in 2013 revealed a nearly equivalent reduction in skin lesions and pruritus using either the Allermyl shampoo or the DOUXO Calm range with a shampoo and mousse combination (Bensignor et al., 2013). Recently, a new formulation of the DOUXO range has been developed (DOUXO^® S3 CALM Shampoo and Mousse, Ceva Santé Animale, France), and preliminary studies have evaluated the clinical significance of its effect in atopic dogs presenting with flares (Gatellet et al., 2020; Ollivier et al., 2022). This study aimed to present additional clinical evidence regarding the benefits of the DOUXO^® S3 CALM range formulation in the management of dogs with irritated and pruritic skin. The results of this study were presented in the context of the available data supporting this range, and a comparison with quantified benefits previously reported in field trials was made using the Core Outcome Set for Canine Atopic Dermatitis (COSCAD'18) standardised approach (Olivry et al., 2018).

MATERIALS AND METHODS

Study design and inclusion and exclusion criteria

The NEMO study was designed as a multicentre, open‐label, uncontrolled field trial and was conducted from February 2019 to April 2021 in 12 veterinary clinics in France, Spain and the United States. Client‐owned dogs of any sex and breed, aged 1 to 12 years, and with a documented history of recurrent flares in which they suffered from irritation and pruritus (Favrot et al., 2010) were initially enrolled. The inclusion criteria were as follows: dogs with Canine Atopic Dermatitis Extent and Severity Index‐4 (Olivry et al., 2014) (CADESI‐04) scores >10 out of a possible score of 180 and a score of 2 to 8 on the 10‐cm Pruritus Visual Analogue Scale (PVAS) (Rybníček et al., 2009); and dogs without ectoparasites and secondary cutaneous or auricular bacterial or fungal infections. The aforementioned evaluations, including clinical and cytological assessments, were performed by every veterinarian. The threshold values of 10 for CADESI‐04 and 2 for the PVAS were as per the previously proposed values for distinguishing normal dogs from those with mild‐to‐moderate CAD (Olivry et al., 2018). Each included dog and all other animals (dogs/cats) in the household received anti‐parasitic treatment that remained effective at the time of inclusion and was systematically continued throughout the study period. Concomitant treatments with other topicals, antimicrobials, antifungals, parenteral depot glucocorticoids and lokivetmab were prohibited during the study, and a wash‐out period was defined (see Table 1 for details). Specific concomitant treatments, such as those using antihistamines, oral glucocorticoids, steroid anti‐inflammatory drugs and immunomodulatory agents (cyclosporine and oclacitinib), were allowed, provided they were initiated before day 0 (D0), administered at a stable dosage regimen for an adequate period, and continued throughout the entire study period. Other concomitant medications, therapies or vaccines were allowed if they did not interfere with the evaluation of the tested products. The initiation of elimination diets was not permitted during the trial period. However, dogs diagnosed with a concomitant food allergy were included in the study if a specific hypoallergenic pet food was initiated at least 8 weeks before inclusion in the study and continued throughout the study.

Table 1.

Allowed/forbidden CAD concomitant treatment

Allowed long‐term CAD treatments	Minimum time before inclusion
Antihistamine treatment	1 week
Oral glucocorticoids treatment	4 weeks
Steroid anti‐inflammatory drugs	4 weeks
Immunomodulatory treatment (cyclosporine and oclacitinib)	8 weeks
ASIT protocol	9 months
Ear cleaner and treatment of ear canal	4 weeks
Nutritional supplements	2 months
Forbidden CAD treatments	Wash‐out period
Lotions, sprays and shampoos	7 days
Topical antiseptic(s)	2 weeks
Antimicrobial or antifungal therapies	4 weeks
Lokivetmab	2 months
Parenteral depot glucocorticoids	2 months

Note: For allowed long‐term treatment, a minimum duration of treatment at a stable dosage regimen before inclusion was mandatory. The treatment had to be carried out during the whole duration of the study. For forbidden treatment, a wash‐out period before inclusion was defined.

Abbreviations: ASIT, Allergen Specific Immunotherapy; CAD, Canine Atopic Dermatitis.

Outcomes

In total, four visits were scheduled on D0, Day 7 (D7), Day 14 (D14), and Day 21 (D21) (Fig. 1). During each visit, complete general examinations were performed, and CADESI‐04 scores were evaluated by veterinarians. Additionally, the presence or absence of adverse reactions was assessed. Owners evaluated their dogs' pruritus level during the previous 24 hours using a validated 10‐cm visual analogue scale (PVAS) (Rybníček et al., 2009). At the end of the study, the pet owners' and veterinarians' overall assessments and satisfaction levels were assessed through questionnaires. Veterinarians were asked to appraise changes in clinical condition (absent or worse, weak, satisfactory, good, and excellent) and skin condition (normal to severe) at D21 compared with that at D0 and provide a general assessment of the product application on a scale from 0 (very poor) to 5 (excellent). The owners were asked to assess the performance and practicality of the protocol using a 4‐point scale: totally disagree, somewhat disagree, somewhat agree, and totally agree. Additionally, they were also asked to evaluate the overall response to the protocol (no response, poor response, fair response, good response or excellent response) (OGATE) (Olivry et al., 2018).

FIG 1.

Study design. Each dog was examined four times by the veterinarian: on Day 0, Day 7, Day 14 and Day 21. In between, the owner applied the same standardised application protocol combining a first application of Ophytrium‐based Shampoo followed by eight Mousse applications (DOUXO^® S3 CALM Shampoo and Mousse, Ceva Santé Animale, Libourne, France). The number of pumps of the mousse to be applied to the dog was estimated on Day 0 according to the dog's body weight, hair length and hair density and varied from 0.5 to 2 pumps per kg. If necessary, the dose was adjusted by the owner at home in order to cover the whole body surface.

Shampoo and mousse application protocol

Each dog underwent a protocol comprising the combined application of an Ophytrium‐based Shampoo and a Mousse (DOUXO^® S3 CALM shampoo and mousse, Ceva Santé Animale, Libourne, France). The protocol consisted of one shampoo and two mousse applications during the first week and three mousse applications weekly during the following 2 weeks. A minimum interval of 2 days and a maximum of 3 were maintained between each application. The shampoo and mousse were applied to the whole body according to the manufacturer's recommendations.

Data analysis

Data were analysed using the SAS software (V.9.4; SAS Institute). Data were two‐tailed with a type one error of 5%. The parameters were analysed using descriptive statistics. Quantitative variables are presented as mean ± standard deviation (SD), and categorical variables are presented as frequency counts and percentages. Changes in the CADESI‐04 and PVAS scores were assessed using linear mixed models. The covariates were the study visit and the baseline as fixed effects. Additional covariates such as coat length, ectoparasite treatments, coat density, and treatment for CAD were initially included in the statistical model and omitted if the p‐values were above 5% with backward selection. Least‐square means with 95% confidence intervals (CIs) were calculated to determine significant differences between visits. Mean changes in CADESI‐04 and PVAS scores from the baselines were assessed, as well as the percentage of dogs with final decreases of ≥50% and ≥70%. As recommended by a recent report regarding short‐term studies (shorter than 6 weeks) (Olivry & Banovic, 2019), the erythema score from the CADESI‐04 (CADESI4‐E score) was additionally evaluated. Satisfaction of the owners and veterinarians was considered a categorical variable and analysed using frequency distributions and number of responses. In addition, to standardise the clinical trial results (Olivry et al., 2018), the COSCAD'18 parameters, considering the Owner Global Assessment of Treatment Efficacy (OGATE), the number of dogs with a PVAS <2, and the number of dogs with a CADESI‐04 <10, were evaluated at the end of the study. The number and percentage of dogs with CADESI‐04 and PVAS scores in different severity categories at various time points were additionally analysed. These values were then compared with those observed in two similar trials in dogs diagnosed with CAD that presented with flares and were treated using similar topical protocols (Gatellet et al., 2020; Ollivier et al., 2022).

RESULTS

Demographics and baseline characteristics

Herein, 38 dogs with CAD were initially enrolled. Of these, 34 dogs were included in the final analyses; three dogs were excluded due to major deviations from the study guidelines (use of prohibited treatment) and one was excluded due to retraction of consent by the owner. The final study population had a mean body weight of 17.8 ± 12.6 kg; most dogs were female (20/34, 58.8%). The mean age of the dogs was 5.6 ± 3.4 years; age ranged from 1 to 13 years, with a median age of 5 years. French bulldogs were the most common breed (12/34). Most dogs had short and thin coats (19/34, 55.9%), six (17.6%) had short and dense coats, and six (17.6%) had long and dense coats. All dogs were regularly treated for external parasites, most often with tablets (24/34, 70.6%) rather than spot‐ons or collars (10/34, 29.4%). Most dogs (19/34, 55.9%) had not received any treatment for CAD at the time of inclusion in the study. The other patients who received regular systemic and/or ear medications are described in Table 2. At baseline, the mean CADESI‐04 score was 24.2 ± 9.3, with scores ranging from 11 to 51, corresponding to skin lesions of mild (30/34 dogs, 88.2%) or moderate (4/34 dogs, 11.8%) intensity. All regions were affected in more than 40% of the dogs, with the highest prevalence in the front paws. The initial PVAS score ranged from 2.1 to 7.7, corresponding to very mild to quite severe pruritus, with a mean of 5.3 ± 1.7.

Table 2.

Percentage and number of dogs (n) receiving Canine Atopic Dermatitis Concomitant treatments at Day 0 (n = 34)

Concomitant treatment for atopic dermatitis	Total (n = 34)
No treatment	55.9% (19)
At least one treatment	44.1% (15)
Systemic treatment	38.2% (13)
Ciclosporin	0.0% (0)
Oclacitinib	17.6% (6)
Prednisolone	8.8% (3)
Allergen Specific Immunotherapy	11.8% (4)
Auricular treatment	11.7% (4)
Hydrocortisone aceponate	8.8% (3)
Triamcinolone	2.9% (1)

Note: Certain Canine Atopic Dermatitis concomitant treatments such as antihistamines, oral glucocorticoids, steroid anti‐inflammatory drugs, long‐term immunomodulatory treatments (cyclosporine and oclacitinib) and auricular treatments were allowed during the study given they were initiated before Day 0, administered at a stable dosage regimen for an adequate period of time, and prolonged during the whole study period. A majority of dogs (55.9%) did not receive any concomitant treatment during the study.

Decrease in the CADESI‐04 score

There was a prompt and significant decrease in the CADESI‐04 score from 24.2 on D0 to 15.1 on D7 (Mean CADESI‐04 score change with 95% CI: −41.8 [−53.1; −30.5]%, p < 0.001), and to 11.9 on D21 (Mean CADESI‐04 score change with 95% CI: −49.4 [−64.6; −34.2]%, p < 0.001) (Fig. 2). At the end of the study, 21/34 dogs (61.8%) and 16/34 (47.1%) achieved ≥50% and ≥70% decrease in their CADESI‐04 scores compared with the initial values, respectively. Twenty out of 34 dogs (58.8%) had CADESI‐04 scores ≤10 at D21. Improvements were observed in all CADESI‐04 categories, even in dogs that were more severely affected (Table 3). Similar significant changes were observed in the CADESI4‐E score, with a mean improvement of 52.7 ± 36.3% from D0 to D21. Noticeable improvement was observed in all body areas (Fig. 3).

FIG 2.

Evolution of the CADESI‐04 score across the time. CADESI‐04 expressed in Mean +/− SEM. *** p < 0.001. CADESI‐04 expressed in mean percent of change compared to Day 0. A significant visit effect of the CADESI‐04 was shown between Day 0 and Day 7/Day 14/Day 21 (p < 0.001). No significant effect of the coat length (p = 0.48), the coat density (p = 0.20), the anti‐ectoparasitic treatment (p = 0.26) or the atopic dermatitis treatment (p = 0.24) were found. After 21 days, the mean CADESI‐04 was just below the remission threshold of 10. On Day 7, a mean reduction of 41.8% was already observed. On Day 21, the mean reduction was close to 50% After 3 weeks of shampoo and mousse application, the CADESI‐04 should decrease by at least 34% (upper limit of the percent confidence interval).

Table 3.

Number and percentage (%) of dogs with CADESI‐04 values in the different severity categories at Day 0 and Day 21 (n = 34)

CADESI‐04 categories	Day 0	Day 21
Remission (0–9)	0/34 (0.0%)	16/34 (47.1%)
Mild (10–34)	30/34 (88.2%)	17/34 (50.0%)
Moderate (35–59)	4/34 (11.8%)	1/34 (2.9%)
Severe (>60)	0/34 (0.0%)	0/34 (0.0%)

Note: At baseline, all dogs were in the category of skin lesion of mild (30/34 dogs, 88.2%) or moderate intensity (4/34 dogs, 11.8%). An improvement was seen in both CADESI‐04 categories with only one dog in the moderate category at the end of the study.

FIG 3.

Distribution of skin lesions by body region. Specific analyses, zone per zone, have been made. Percentage of dogs affected on each body location at Day 0 and Day 21 are shown in the Figure (n = 34). After 21 days of product application and for all body regions, there was a decrease in the number of affected dogs. Only four body regions (abdomen, ears, perilabial area and paws) were still affected in 40–60% of dogs. In terms of mean CADESI‐04 score per affected area, the two regions mostly affected initially (perilabial area: mean score = 2.4/76.5% of dogs affected at Day 0; front paws: mean score = 2.2/94.1% and 91.2% at Day 0) remain quite affected at the end of the 3‐week treatment period (perilabial area: mean score = 1.8/52.9% of dogs at Day 21; front paws: mean = 1.7 and 1.9/47.1% and 50.0% of dogs at Day 21).

Reduction of pruritus

A rapid and significant decrease in the PVAS score was observed during the study. The mean PVAS score decreased from 5.3 ± 1.7 on D0 to 3.9 ± 1.9 on D7 (mean score change: −20.2% [−35.6; −4.8]%, p < 0.001). At the end of the study, the mean PVAS score was 3.6 ± 2.4, with a mean improvement of −30.8 (−45.0; −16.5) (p < 0.001) (Fig. 4). Improvement was observed even in cases of moderately severe itching. From D14 to D21, 11/34 dogs (32.4%) presented with PVAS scores <2, corresponding to the PVAS scores of normal dogs. At the end of the study, 15/34 dogs (44.1%) achieved a ≥50% decrease in pruritus, and 15/34 dogs (44.1%) achieved a ≥2 cm decrease in their PVAS scores.

FIG 4.

Evolution of the PVAS score across the time. PVAS score expressed in Mean +/− SEM. *** p < 0.001PVAS score expressed in mean percent of change compared to Day 0. A significant visit effect of the PVAS was shown between Day 0 and Day 7/Day 14/Day 21 (p < 0.0001). No significant effect of the coat length (p = 0.20), the coat density (p = 0.15), the anti‐ectoparasitic treatment (p = 0.11) or the atopic dermatitis treatment (p = 0.36) were found. A reduction from baseline of 20.2, 27.8 and 30.8% was observed on Day 7, Day 14 and Day 21 respectively. A mixed model with repeated measures was use to analyse the VAS evolution. Visit and the baseline were used as fixed effects and the dog number in the center was used as a random effect. Other parameters were tested but were not significant (coat length (p = 20), ectoparasite treatment (p = 0.11), treatment for atopic dermatitis (p = 0.71), coat density (p = 0.15) and country (p = 0.26). There was a significant change between Day 0 and all visits (p < 0.0001).

Veterinarians' overall assessment and satisfaction

Most dogs (22/34, 64.7%) showed an improvement following the implementation of the protocol. Regarding the status of the skin condition after 21 days, 9/34 dogs (26.5%) were considered normal and 15/34 (44.1%) had mild‐intensity signs. At the end of the study, compared with D0, veterinarians considered the improvements to be satisfactory, good or excellent in 66.7% of the cases (30.3%, 30.3% and 6.1%, respectively). The response to the protocol was considered minimal in 24.2% of the cases and absent or worse in the remaining cases.

Pet owners' overall assessment and satisfaction

After 21 days, pet owners considered the protocol to be effective in 72.7% of cases and practical in100% of cases. Overall, they highlighted a fair, good or excellent response to the protocol (OGATE) in 72.7% of cases (24.2%, 36.4% and 12.1%, respectively). Regarding the products, pet owners liked the characteristics (odour and texture) of the shampoo and mousse in 100% and 90.9% of cases, respectively. They considered their package to be practical, making the application easy in 100% of the cases for the shampoo and in 97% of cases for the mousse. Most owners (72.7%) reported that their dogs had nice hair and skin.

COSCAD'18

COSCAD'18 parameters after the application of the standardised topical protocol for 21 days are presented in Table 4. The three COSCAD'18 parameters (CADESI‐04 score, PVAS score and OGATE) on D21 are visually represented in Fig. 5. The correlation coefficient between the CADESI‐04 and PVAS scores on D21 was 0.62.

Table 4.

Core outcome set for CAD (COSCAD'18) results after 21 days of standardised topical application with DOUXO^® S3 CALM range)

Study	Basal values (Day 0)	CADESI‐04 < 10 (Day 21) Relative frequency (%)	PVAS < 2 (Day 21) Relative frequency (%)	OGATE good‐to‐excellent (Day 21) Relative frequency (%)
NEMO	CADESI‐04: Remission (0–9): 0/34 (0.0%) Mild (10–35): 30/34 (88.2%) Moderate (36–59): 4/34 (11.8%) Severe (≥ 60): 0/34 (0.0%) Mean score (SD): 24.2 (9.3)\ PVAS: Mean score (SD): 5.3 (1.7)	16/34 (47.1%)	11/34 (32.4%)	16/34 (47.1%)

FIG 5.

Correlation between the CADESI‐04 score, the VAS score and OGATE (n = 34) at Day 21. A visual presentation of the three COSCAD 18 parameters (CADESI‐04 score, PVAS score and OGATE) on Day 21 is given. A coefficient of correlation r = 0.62 was reported.

Adverse events

Herein, product tolerance was deemed good. Only one case was linked to the administration of the shampoo, with the appearance of erythema and papules after application. The dog was then withdrawn from the study. Three dogs presenting with superficial pyoderma were withdrawn from the study and administered antibiotics. Two dogs were excluded from the study because of worsening of their skin status and/or pruritus; however, they were included in the analysis, with their last CADESI‐04 and PVAS scores imputed up to the end of the study. The remaining four adverse events did not lead to withdrawal from the study: one superficial eye ulcer that started on D4, one puncture behind an ear that could have been due to an opossum bite wound, and gastrointestinal signs (diarrhoea and emesis) that spontaneously resolved within 1 day.

DISCUSSION

The study included 34 dogs presenting with pruritus and inflamed skin, with CADESI‐04 scores >10. All dogs presented with mild to moderate CADESI‐04 scores (88.2% and 11.8%, respectively) and very mild to severe pruritus (corresponding to PVAS scores of 2.1 to 7.7). The topical protocol using Ophytrium‐based products (a combination of shampoo and eight subsequent mousse applications for 3 weeks) resulted in a quick and significant improvement in both skin appearance and pruritus. These results illustrate the soothing properties of Ophytrium and its clinical benefits. Indeed, in vitro studies have demonstrated that Ophytrium can lead to a decreased secretion of proinflammatory cytokines (IL‐8, TSLP and IL‐13) (Ollivier et al., 2019). Shampoos remove dirt, debris, scales, or allergens present on the skin surface. However, as they are rinsed off, their ingredients come into contact with the skin within a relatively short time. In addition, shampoo applications are not always accepted by pets and require adequate facilities and time (the stand time is usually 5 to 10 min). This can demotivate the owners in the long term. A retrospective study conducted in the USA showed that 5 years after the diagnosis of CAD, only 18% of pet owners continued washing their dogs at least once a week (Dell et al., 2012). A study conducted in 2010 showed that 32% of pet owners of atopic dogs felt that their dog's treatment was a major burden (Linek & Favrot, 2010). In the management of canine pruritus, while efficacy is critical, the nature of the treatment and the frequency of administration are equally important because they directly affect adherence, caregiver burden and overall satisfaction with care. A holistic approach that considers both efficacy and the caregiver's experience tends to yield the best outcomes for both dogs and their owners (Spitznagel et al., 2021, 2024). Accordingly, taking both the complexity of the treatment for the owner and its proven clinical interest into consideration is crucial to ensure successful adherence to the complete treatment plan for CAD. Previously, 56 out of 68 pet owners (82%) considered a twice‐weekly shampoo application to be constraining, difficult, or impossible (Bensignor et al., 2013). Furthermore, a lower frequency of application has been demonstrated to be able to alter the performance of a product (Löflath et al., 2007). Leave‐on formulations allow ingredients to stay in direct contact with the skin for longer periods for prolonged action. In the authors' opinion, the protocol in this study offers the benefits of the shampoo cleaning the skin and fur, while massaging with the mousse would allow the ingredients to remain in direct contact with the skin and, at the same time, reinforce the pet‐owner bond. Leave‐on formulations could then be expected to encourage compliance, which is key to managing lifelong skin disorders. The results of this study are encouraging in terms of compliance with 95.5% of pet owners considering the protocol to be practical. Avoiding allergens and other factors contributing to the recurrence of signs is essential. However, in cases of relapses, increasing the dose or frequency of systemic medication is not always possible or recommended because of potential side effects. Another interesting result of this study was that there was no significant difference in outcomes irrespective of the presence of concurrent treatment, suggesting that topical products can effectively complement concurrent treatment without interference with systemic drugs. Most atopic dogs require a multimodal approach for the effective management of their chronic condition, adapted to each patient and stage of dermatitis. This combined modality can be used during acute flares of the disease, as well as during the chronic phase.

Protocol

To harmonise therapeutic trials and better inform veterinarians and pet owners when comparing various interventions available for CAD, following the set of outcome measures detailed in COSCAD'18 is encouraged (Olivry et al., 2018). The results of this study showed significant benefits after 21 days of the standardised topical protocol when added to stable concomitant systemic CAD treatment in the context of atopic flare‐ups and moderate skin lesions, with 47.1% of the dogs achieving remission according to the CADESI‐04 score (CADESI‐04 <10), and 32.4% of the dogs achieving remission in terms of pruritus (PVAS <2). Good‐to‐excellent OGATE scores were reported in 47.1% of cases.

The primary limitation of this study is the lack of a control group. Considering the potential impact on the welfare of the dogs, no placebo group was included for ethical reasons, as no substantial improvements in irritation or pruritus in the control or vehicle groups after 4 weeks were previously reported (Cosgrove et al., 2013; Horvath‐Ungerboeck et al., 2009; Marsella et al., 2019; Steffan et al., 2005). This observation has been confirmed in most long‐term studies (Ferguson et al., 2006; Marsella et al., 2017, 2020; Puigdemont et al., 2013). Consequently, dogs were considered as their own controls, and improvements were judged against their baseline values. Long‐term studies may be interesting to observe the evolution of the benefit of a concomitant standardized topical protocol with time, particularly its ability to prevent relapses.

CONCLUSIONS

The standardized topical protocol described herein, when used alone or as an adjuvant treatment to systemic therapy, significantly improved both CADESI‐04 scores and pruritus in atopic dogs presenting with skin flares and mild‐to‐moderate intensity skin lesions. Frequent use of shampoo can be perceived as a constraint in the long term; conversely, using a leave‐on mousse formula is convenient and time‐sparing and the massage during the application can be a pleasant shared moment between pets and owners. All of these factors are expected to favour compliance, which is of major importance in the management of lifelong skin disorders such as CAD. In addition, tolerance to the products was good and no serious adverse events were reported.

Author contributions

N. Savelli: Writing – review and editing (equal). A. Cozar: Writing – review and editing (equal). M. Abdesselam: Writing – review and editing (equal). E. Ollivier: Conceptualization (equal); methodology (equal). M. Gatellet: Conceptualization (equal); methodology (equal). R. Kesteman: Conceptualization (equal); methodology (equal). P. Fiora: Investigation (equal). J.‐F. Jamet: Investigation (equal). V. Mahé: Investigation (equal). L. Ordeix: Investigation (equal). T. Blondel: Data curation (equal); formal analysis (equal). C. Zemirline: Conceptualization (equal); methodology (equal). X. De Jaeger: Conceptualization (equal); methodology (equal).

Conflicts of interest

Alicia Cozar, Elodie Ollivier, Marina Gatellet, Roxane Kesteman, Thomas Blondel, Claudine Zemirline, and Xavier De Jaeger are employees of Ceva Santé Animale. Nadège Savelli and Marion Abdesselam are Consultants for Ceva Santé Animale. The remaining authors received fees from Ceva Santé Animale for recruiting cases.

Data availability statement

The datasets generated for this study are available on request to the corresponding author.