Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study. - ND

• Conditions: Atopic dermatitis; MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitis

• Registration Number: EUCTR2008-003485-25-IT
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Age between 2 and 7 years, - Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party, - Whose IGA score is  1 at inclusion, - Whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child`s participation in the study, - Whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints, - If required by national regulations, registered with a social security or health insurance system.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Criteria related to pathologies - Acute phase of atopic dermatitis with mild/moderate/severe erythema, excoriation, crust, oozing, exudation, - Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation, - Primary bacterial, viral, fungal or parasitic infectio, Ulcerated lesions, acne or rosacea, - Dermatological disease other than atopic dermatitis liable to interfere with the assessment, - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study, - Immunosuppression, - History of hypersensitivity or intolerance to one of the substances of content of the study drug or Locapred, or to cosmetics. * Criteria related to treatments - Use of oral corticosteroids or immunosuppressants during the last month, - Use of antibiotics or topical corticosteroids during the last week, - Use of non-steroid anti-inflammatory drugs or antihistamines during the last week, - Use of homeopathic treatment during the last 2 months, - Regular use of food supplements that could, in the opinion of the investigator, modify skin properties. * Criteria related to the population - Child with a brother or sister already included in this study, - Patient and/or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing, - Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship, - Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency, - Participation to another clinical trial or being in the exclusion period of another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.;Secondary Objective: To evaluate the impact of the treatment on xerosis: evolution of the SRRC (Scaling, Roughness, Redness, Cracks/Fissures) score, To evaluate the impact of the treatment on the topical corticosteroid use, To assess the overall efficacy of the treatment by the parents and the investigator, To document the clinical, local and systemic, safety of the treatment over the study duration;Primary end point(s): Mean POEM score measured weekly, over the 12 weeks of treatment.