Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

Detailed Description
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The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice. The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution). The following hypotheses are used for the estimation of the sample size calculation: Power (1 - β) = 80% Two-sided significance level (α) = 5% Expected inter-group difference = 0.6g Standard deviation = 1.4g. Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA). Continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). For categorical variables, subject counts and percentages will be provided. Analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (Shapiro-Wilk test).

Official Title
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Impact of the Daily Use of the Tested Emollient on Corticosteroids Consumption in Patients Minimum 3 Years Old With Atopic Dermatitis (SCORAD 20-30) Versus Their Usual Emollient

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Lipikar Baume AP+M
* Other: Usual emollient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features) mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30) able to apply the emollient (each morning and evening) during a three-month period Exclusion Criteria: presenting with another dermatological condition that could interfere with clinical evaluation having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0 who intend to expose themselves to the sun during the trial

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lipikar Baume AP+M<br>The group applies Lipikar Baume AP+M twice daily for 3 months. Participants have 4 visits (Day0, Day 28, Day56, Day84) with different outcome measures including self-evaluations). | Other: Lipikar Baume AP+M<br>* application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment<br>|
| Usual emollient<br>The group applies their usual emollient twice daily for 3 months. Participants have 4 visits (Day0, Day28, Day56, Day84 with different outcome measures including self-evaluations). | Other: Usual emollient<br>* application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of treatments | the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications) | from baseline to Day84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in SCORing Atopic Dermatitis (SCORAD) measure | evaluation of SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications) | from baseline to Day84 | 
| change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure | evaluation of PO-SCORAD by the patient in relation with the emollient consumption (weight of product and number of applications) | from baseline to Day84 | 
| change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure | evaluation of LOCAL SCORAD by the dermatologist in relation with the emollient consumption (weight of product and number of applications) | from baseline to Day84 | 
| change in cutaneous discomfort | evaluation of skin sensation (itching, tingling, burning) by the patient on a 4-point scale (from absence to severe) | from baseline to Day84 | 
| change in global efficacy | evaluation of global efficacy by the patient on a 4-point scale (from nil to excellent) | from Day28 to Day84 | 
| change in global tolerance | evaluation of global tolerance of the treatment (emollient + corticosteroid) by the patient on a 4-point scale (from nil to excellent) | from Day28 to Day84 | 
| change in Patient Benefit Index (PBI) measure | questionnaire filled in by the patient or the patient's parents (whether the statement applies to the situation or not, possible answers: not at all, somewhat, moderately, quite, very, does not apply to me) | from baseline to Day84 | 
| change in the quality of life (patients aged 18 years or over) | questionnaire about the Atopic Burden Scale for Adults (ABS-A) with the following scale: never, rarely, sometimes, often, very often, constantly, not applicable. A higher score means a higher burden. | from baseline to Day84 | 
| change in the quality of life (patients aged less than 18 years) | questionnaire about the Atopic Dermatitis Burden Scale for the Family (ABS-F) with the following scale: no, without hesitation; I don't know; maybe; yes, without hesitation; not applicable. A higher score means a higher burden. | from baseline to Day84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, corticosteroids, SCORAD