Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467362
• Other study ID #: V00034 CR 3 12 1B
• Secondary ID: 2011-003295-37
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2011
• Last updated: February 20, 2013
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Estonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• V0034CR01B
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
• Vehicle cream
Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
• desonide 0.1% cream
cream, once a day (in the evening) during flares

Other:
• Foaming gel
for the washing and cleaning

Locations

Country	Name	City	State
Estonia	Estonia	Tallinn
Estonia	Estonia	Tartu
France	France	Bordeaux
France	France	Martigues
France	France	Nantes
France	France	Nice
France	France	Poitiers
Lithuania	Lithuania	Vilnius
Poland	Poland	Bialystok
Poland	Poland	Inowroclaw
Poland	Poland	Lódz
Poland	Poland	Olesnica
Poland	Poland	Plock
Poland	Poland	Poznan
Poland	Poland	Strzelce Opolskie
Poland	Poland	Warszawa
Poland	Poland	Zyrardów
Romania	Romania	Brasov
Romania	Romania	Bucharest
Romania	Romania	Constanta
Romania	Romania	Craiova
Romania	Romania	Iasi
Romania	Romania	Ploiesti
Romania	Romania	Sibiu
Romania	Romania	Targu Mures

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Estonia,  France,  Lithuania,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Hydration Index score : measurement of the skin hydration		Day 1, Day 14, Day 28, Day 56 and Day 84	No
Secondary	Xerosis score evolution over the different time-ponts during open label period		At Visit1 (Day 1) and at Day 56 and Day 84	No
Secondary	Xerosis Visual Analogue Scale (evaluation skin dryness)		Day 1, Day 14, Day 28, Day 56 and Day 84	No
Secondary	Scoring for Atopic Dermatitis (SCORAD) : measurement of objective symptoms of Atopic Dermatitis.		Day1, Day 28, Day 56 and Day 84.	No
Secondary	Overall assessment of treatment efficacy by the investigator		Day 28 and Day 84	No
Secondary	Overall assessment of treatment efficacy and use by the parent(s)/guardian(s)		at Day 28 and at Day 84	No
Secondary	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	Yes
Secondary	Topical corticosteroid assessment		Day 7, Day 14, Day 21, Day 28, Day 56 and Day 84	No