Pierre Fabre Laboratories have developed a cream with medical device status, RV4421B-EV0407 indicated for the treatment of eczemas, including atopic eczema, contact eczema and chronic hand eczema.
This product is already marketed in several countries. The objective of this clinical study is to evaluate the safety and efficacy of the study product when used alone or in association with topical corticosteroid therapy, in an ethnically diverse adult and pediatric population (including dark skin) and over a long period of time with a 12-week follow-up.
5 visits are planned:
* Visit 1: Inclusion visit (Day 1) * Visit 2: Intermediate visit (Phone visit - Between Day 8 and Day 15) * Visit 3: Intermediate visit (Day 29 ± 3 days) * Visit 4: Intermediate visit (Day 57 ± 3 days) * Visit 5: End of study visit (Day 85 ± 3 days)
Group 1 (infants group): from 3 months to 23 months old included
Group 2 (children group): from 24 months to 12 years old included
Group 3 (teenagers & adults group): from 13 years old
Subject with a diagnosis of atopic dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams HC, Burney PG, et al.).
Infant with Atopic Dermatitis lesions or prevailing xerotic areas located on the diaper (groups 1 & 2)
Subject with history of allergy or intolerance to any of the study product(s) ingredients or material used for the research
Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo…) on the studied areas liable to interfere with the study assessments
Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements