Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: V0034CR01B; Drug: Vehicle cream; Drug: desonide 0.1% cream; Other: Foaming gel

• Registration Number: NCT01467362
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V0034CR01B	V0034CR01B	-
V0034CR01B	desonide 0.1% cream	-
V0034CR01B	Foaming gel	-
Vehicle cream	Vehicle cream	-
Vehicle cream	desonide 0.1% cream	-
Vehicle cream	Foaming gel	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Lithuania; 🇱🇹 Vilnius, Lithuania

Poland; 🇵🇱 Żyrardów, Poland

Estonia; 🇪🇪 Tartu, Estonia

France; 🇫🇷 Poitiers, France

Romania; 🇷🇴 Targu Mures, Romania