Atopic Dermatitis Clinical Trial
Official title:
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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