Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Study Overview
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Brief Summary
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Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy. The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.

Official Title
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Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: V0034CR01B
* Drug: Vehicle cream
* Drug: desonide 0.1% cream
* Other: Foaming gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting with atopic dermatitis, dry skin, objective SCORAD < 15, With xerosis on the body and a xerosis score > = 2 (SCORAD sub-score) on the anterior part of lower limbs, Exclusion Criteria: Acute phase of atopic dermatitis Severe form of atopic dermatitis

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V0034CR01B<br> | Drug: V0034CR01B<br>* Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days<br>Drug: desonide 0.1% cream<br>* cream, once a day (in the evening) during flares<br>* Other names: Locapred;Other: Foaming gel<br>* for the washing and cleaning<br>* Other names: Pediatril;|
| Placebo Comparator: Vehicle cream<br> | Drug: Vehicle cream<br>* Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days<br>Drug: desonide 0.1% cream<br>* cream, once a day (in the evening) during flares<br>* Other names: Locapred;Other: Foaming gel<br>* for the washing and cleaning<br>* Other names: Pediatril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Xerosis score: mean evolution over the different time-points of double-blind period |  | During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydration Index score : measurement of the skin hydration |  | Day 1, Day 14, Day 28, Day 56 and Day 84 | 
| Xerosis score evolution over the different time-ponts during open label period |  | At Visit1 (Day 1) and at Day 56 and Day 84 | 
| Xerosis Visual Analogue Scale (evaluation skin dryness) |  | Day 1, Day 14, Day 28, Day 56 and Day 84 | 
| Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis. |  | Day1, Day 28, Day 56 and Day 84. | 
| Overall assessment of treatment efficacy by the investigator |  | Day 28 and Day 84 | 
| Overall assessment of treatment efficacy and use by the parent(s)/guardian(s) |  | at Day 28 and at Day 84 | 
| Assessment of the local tolerability and the systemic safety (reported adverse events) |  | Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 | 
| Topical corticosteroid assessment |  | Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerosis, dry skin, dermatitis, pruritus, eczema, emollient, corticosteroid