RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS. - Not applicable

• Conditions: Patient presenting with an atopic dermatitis.; MedDRA version: 8.0Level: LLTClassification code 10040785

• Registration Number: EUCTR2005-002803-18-DE
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-16
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients, male or female infants, presenting with the following criteria may be included:
- age between 3 and 24 months,
- presenting with an atopic dermatitis according to the diagnostic criteria of the UK Working party,
- with SCORAD > or = 20 and < 50,
- whose xerosis is > or = 1 (on the SCORAD scale scored from 0 to 3),
- requiring topical corticosteroid treatment, mild potent, on the body and/or the face.
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

Patients presenting with any of the following criteria will not be included:
- Severe evolutive form or exsudative form of atopic dermatitis requiring systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- 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,
- Immunosupression,
- History of allergy or intolerance to cosmetics,
- Use of antibiotics, corticosteroids or immunosuppressants since less than 15 days and/or use of non-steroid anti-inflammatory drugs or antihistamines since less than 1 week,
- Use of a drug treatment able to modify the skin moisturizing or stop of this treatment since less than one week (if any, the inclusion should be delayed),
- Use of cosmetic products (moisturising, emollient or other) since less than one week (if any, the inclusion should be delayed),
- Use of complement foods able to modify skin during the study duration (vitamin A, probiotics…),
- Intense exposure to sun within the month preceding the study.

Study & Design

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