Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Pierre Fabre

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Other: Foaming gel; Drug: desonide 0.1% cream; Drug: Vehicle cream; Drug: V0034CR01B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467362

V00034 CR 3 12 1B

2011-003295-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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251 participants in 2 patient groups, including a placebo group

V0034CR01B

Experimental group

Treatment:

Drug: V0034CR01B

Drug: desonide 0.1% cream

Other: Foaming gel

Vehicle cream

Placebo Comparator group

Treatment:

Drug: Vehicle cream

Drug: desonide 0.1% cream

Other: Foaming gel