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
Parallel
RV4421B- EV0407
DeviceMedical device. Product application on studied areas, 5 to 15 minutes after corticosteroids application, if applicable. The maximum duration of application of medical device is 87 days.
Local tolerance of the product RV4421B-EV0407 on studied areas
The results of the local tolerance will take into account the clinical signs observed by the investigators and the signs reported by the subject and/or the subjects' parent(s) or guardian(s), based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
Local tolerance of the product RV4421B-EV0407 on studied areas at several timepoints
using the same 5-point scale as the primary criterion and same rules.
Recording of adverse events
At each visit, the occurrence of Adverse Events since the last visit will be determined by the subject's / parent(s) or guardian(s) spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation. All AEs will be reported on the CRF
Local-SCORAD (SCORing Atopic Dermatitis)
Local -SCORAD (SCORing Atopic Dermatitis) will be assessed by the investigator on target area (= area most representative of Atopic Dermatitis severity of the whole body) on a scale ranged from 0 to 15, at each visit (except the Visit 2). Each of 5 objective signs of the SCORAD (Erythema, Oedema/papulation, Oozing/Crusts, Excoriation, and Lichenification) will be rated from 0 (absent) to 3 (severe) independently
SCORAD (SCORing Atopic Dermatitis)
SCORAD will be assessed by the investigator at each visit (except the Visit 2). The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner. The complete system is called SCORAD index and takes into account the extent of the lesions, the severity of the clinical signs (objective signs) and the subjective symptoms (pruritus, sleep loss) reported on a Visual Analogue Scale (VAS). The extent of lesions is scored on an evaluation form. The intensity is determined by grading each of the six items on a scale from 0 to 3 (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness). Each item should be scored on the most representative area for a given intensity item.
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