Status:
COMPLETED
Evaluation of the Effect of the Product RV4660C CY0203 on Clinical, Biometrological and Biological Parameters in Adults With Mild to Moderate Atopic Dermatitis, an Exploratory Study
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Mild to Moderate Atopic Dermatitis
Eligibility:
FEMALE
18+ years
Brief Summary
In this exploratory study, we assessed the efficacy of a cosmetic product in adults suffering from mild to moderate atopic dermatitis. This exploratory study has been conducted as a monocentric non ra...
Eligibility Criteria
Inclusion
- Main inclusion criteria :
- Woman 18 years or older
- Non-menopausal woman
- Subject with phototype I, II, III, IV as classified by Fitzpatrick
- Subject with AD according to "The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis"
- Mild to moderate AD with SCORAD (SCORing Atopic Dermatitis) between 20 and 40 inclusive
- Subject who had at least 1 inflammatory AD flare-up in target areas in the year prior to inclusion visit
- Subject with at least one measuring target area on each upper or lower limb and defined as a typical AD flare-up area in the opinion of the subject
- Subject with at least one target area on each upper or lower limb with the following SCORAD target signs (between 3 and 18):
- Erythema ≥ 1
- Xerosis \> 1
- Subject with pruritus intensity ≥ 3 on SCORAD analog visual scale (VAS)
- Main non-inclusion criteria:
- Subject with superinfected AD
- Subject with a known history of allergy or intolerance to the components of the study product
- Subject with a dermatological condition other than AD, or characteristics (for example, tattoo) on the study areas, likely to interfere with the study evaluations according to the investigator's opinion
- Subject with another dermatological condition, acute or chronic pathology, or history of pathology, likely to interfere with study evaluations, or considered dangerous to the subject or incompatible with study requirements, in the opinion of the investigator
- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational product according to the investigator's assessment
Exclusion
Key Trial Info
Start Date :
October 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT07166497
Start Date
October 30 2023
End Date
December 22 2023
Last Update
September 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Skin Research Center
Toulouse, France, France, 31000