Patient presenting with an atopic dermatitis. MedDRA version: 8.0 Level: LLT Classification code 10040785
Conditions
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: To evaluate the consumption of topical corticosteroid. To evaluate the product effect on xerosis and the associated pruritus. To document the clinical, local and systemic, safety.;Primary end point(s): Evolution of SCORAD from D1 to D8, D15 and D22 (mean score evolution). | — |
Countries
Estonia, Finland, Germany, Latvia
Outcome results
None listed