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

Pierre Fabre

Status: Completed

Conditions: Mild to Moderate Atopic Dermatitis

Treatments: Other: Cosmetic product RV4660C CY0203

Study type: Observational

Funder types: Industry

Identifiers

NCT07166497

RV4660C20230530

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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):

  1. Erythema ≥ 1
  2. 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

Trial design

21 participants in 1 patient group

Test Group

Treatment:

Other: Cosmetic product RV4660C CY0203