ONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR. A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS, DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN - Not applicable
- Conditions
- Patients presenting with an atopic dermatitis, out of flare at the inclusion.MedDRA version: 8.0 Level: LLT Classification code 10040785
- Registration Number
- EUCTR2005-003396-21-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients, male or female, presenting with the following criteria may be included:
- age between 3 months and 7 years included
- presenting with an atopic dermatitis according to the diagnostic criteria of the UK Working party
- whose IGA score is < or = 1 at inclusion
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:
* Criteria related to pathologies·
- Acute phase of atopic dermatitis with moderate/severe erythema, excoriation, crust, oozing, exsudation,
- Severe evolutive 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.
* Criteria related to treatments·
- Use of oral corticosteroids or immunosuppressants since less than 1 month,
- Use of antibiotics, topical corticosteroids since less than 15 days,·
- Use of non-steroid anti-inflammatory drugs or antihistamines since less than 1 week.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the overall benefit of a regular treatment by the emollient V0034CR in the management of atopic dermatitis: reduction of corticosteroids consumption, reduction of flares;<br> Secondary Objective: To evaluate the Quality of Life over the study duration<br> To evaluate the product effect on the skin dryness and pruritus<br> To document the clinical, local and systemic, safety over the study duration<br> ;Primary end point(s): Number of days of application of a moderately potent corticosteroid
- Secondary Outcome Measures
Name Time Method