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: 8.0 Level: LLT Classification code 10040785
- Registration Number
- EUCTR2005-002803-18-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the short term efficacy of the emollient V0034CR in addition to a moderately potent topical corticosteroid in the acute phase of treatment of atopic dermatitis, by reducing the disease severity.;<br> Secondary Objective: To evaluate the consumption of topical corticosteroid.<br> To evaluate the product effect on xerosis and the associated pruritus.<br> To document the clinical, local and systemic, safety.<br> ;Primary end point(s): Evolution of SCORAD from D1 to D8, D15 and D22 (mean score evolution).
- Secondary Outcome Measures
Name Time Method