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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
251
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
cream, once a day (in the evening) during flares
for the washing and cleaning
Estonia
Tallinn, Estonia
Estonia
Tartu, Estonia
France
Bordeaux, France
France
Martigues, France
France
Nantes, France
France
Nice, France
France
Poitiers, France
Lithuania
Vilnius, Lithuania
Poland
Bialystok, Poland
Poland
Inowrocław, Poland
...and 15 more locations
Xerosis score: mean evolution over the different time-points of double-blind period
Time frame: During 28 days (Day 1, Day 7, Day 14, Day 21 and Day 28)
Hydration Index score : measurement of the skin hydration
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Xerosis score evolution over the different time-ponts during open label period
Time frame: At Visit1 (Day 1) and at Day 56 and Day 84
Xerosis Visual Analogue Scale (evaluation skin dryness)
Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84
Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.
Time frame: Day1, Day 28, Day 56 and Day 84.
Overall assessment of treatment efficacy by the investigator
Time frame: Day 28 and Day 84
Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)
Time frame: at Day 28 and at Day 84
Assessment of the local tolerability and the systemic safety (reported adverse events)
Time frame: Day 1, Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
Topical corticosteroid assessment
Time frame: Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84
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