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Efficacy Emollient on Xerosis in Children With Atopic Dermatitis

NCT01467362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2013-02-21

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

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

DRUG

desonide 0.1% cream

cream, once a day (in the evening) during flares

OTHER

Foaming gel

for the washing and cleaning

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Franck BORALEVI, Pr · Health centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Estonia
  • France
  • Lithuania
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467362 on ClinicalTrials.gov