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

NCT ID: NCT07166497

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2023-12-22

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 randomized study.

To perform this clinical study, 21 non menopausal women, aged from 18 years and older, suffering from mild to moderate atopic dermatitis were enrolled.

The subjects applied the investigational product once a day, in the evening on the whole body/ off face for up to 31 days.

4 visits were planned:

• Visit 1 - Day 1 - Inclusion visit
• Visit 2 - Day 8 - Intermediate visit
• Visit 3 - Day 29 (± 3 days) - Intermediate visit
• Visit 4 - Day 36 (± 3 days) - End of study visit

Conditions

Mild to Moderate Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Test Group

Cosmetic product RV4660C CY0203

Intervention Type: OTHER

The product was applied once a day, in the evening, on the whole body/ off face on previously cleansed skin. The product was warmed in the hands before being applied in wide movements.

Interventions

Cosmetic product RV4660C CY0203

The product was applied once a day, in the evening, on the whole body/ off face on previously cleansed skin. The product was warmed in the hands before being applied in wide movements.

Intervention Type: OTHER

Eligibility Criteria

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):

1. Erythema ≥ 1

2. Xerosis > 1

• Subject with pruritus intensity ≥ 3 on SCORAD analog visual scale (VAS)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skin Research Center

Toulouse, France, France

Countries

France

Other Identifiers

RV4660C20230530

Identifier Type: -

Identifier Source: org_study_id