In-Use Tolerance Study Under Dermatological and Pediatric Controls of Sunscreen in Children With Atopic Dermatitis

NCT ID: NCT07194408

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2024-02-16

Brief Summary

Atopic dermatitis is a chronic skin condition requiring sun protection, yet research on sunscreen effectiveness and skin tolerance in Atopic Dermatitis is limited. This study evaluates a broad-spectrum SPF50+ sunscreen on 22 children with Atopic Dermatitis, assessing skin tolerance through dermatologic and pediatric controls.

Detailed Description

Atopic dermatitis is a chronic skin condition that necessitates sun protection, yet there is limited research on the effectiveness of sunscreens and skin tolerance in Atopic Dermatitis.

Objectives: This study aims to evaluate the tolerance of a broad-spectrum SPF50+ sunscreen in children with Atopic Dermatitis, monitored through dermatological and pediatric assessments.

Methods: This study is conducted on 22 children with Atopic Dermatitis confirmed using the SCORAD index (15-25).

The protocol includes 2 visits and assessments as follow:

• Visit 1: Inclusion (Day 1) - Before and immediately after application (10 to 30 minutes), the investigator conducts a clinical evaluation of the dermatological tolerance of the investigational product. SCORAD evaluation by the dermatologist and pediatrician together is performed on Day 1.
• Home Application Period: Day 1 to Day 22 - Continued application of the sunscreen at home in real conditions of use
• Visit 3: End of Study (Day 22) -The investigators conduct a clinical evaluation of the dermatological tolerance of the investigational product. In addition, a questionnaire is used to evaluate global and perceived efficacy of the sunscreen.

Conditions

Atopic Dermatitis (AD); SCORAD Index (15-25)

Study Design

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

Study Groups

Test group

Children intended to use Sunscreen RV4620A RP2552 product

Sunscreen RV4620A RP2552

Intervention Type: OTHER

Dermo-cosmetic product, Broadspectrum Sunscreen RV4620A RP2552, very high protection product.

Instructions for product use given to the subjects: Apply before and during sun exposure, at least twice daily. During sun exposure, applications must be renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, apply the product in the morning and at the beginning of the afternoon.

Interventions

Sunscreen RV4620A RP2552

Dermo-cosmetic product, Broadspectrum Sunscreen RV4620A RP2552, very high protection product.

Instructions for product use given to the subjects: Apply before and during sun exposure, at least twice daily. During sun exposure, applications must be renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, apply the product in the morning and at the beginning of the afternoon.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Criteria related to the population:

• phototype: I to IV;
• face and body skin type: all skin types;
• subjects must be registered with health social security or health social insurance (if required by national regulations);
• subjects' parent(s)/ legal representatives having signed their written Informed Consent form for their participation in the study and a photograph authorization;
• subjects' parent(s)/ legal representatives certifying the truth of the personal information declared to the Investigator;
• Health Status: Considered a "healthy subject" by the Investigators (excluding SCORAD considerations).

Criteria Related to Atopic Dermatitis:

• Subject must present atopic dermatitis according to the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis, with mild atopic dermatitis indicated by a SCORAD score of 15 to 25 (inclusive), determined by a dermatologist and a pediatrician together.

Criteria Related to Population:

• Subjects who have participated in another clinical trial within the week before the inclusion visit, or for a longer period if deemed necessary by the Investigator.
• Subjects currently participating or planning to participate in another clinical trial during the study, either in the same or a different investigation center.

Criteria Related to Subject's Health:

• Subjects experiencing a flare of atopic dermatitis.
• Subjects with dermatological conditions that may interfere with study data or are considered hazardous by the Investigator (e.g., pityriasis versicolor, severe pigmentation disorders such as vitiligo, melasma, multiple lentigines, numerous or large congenital nevi).
• Subjects with a personal medical history that may interfere with study data or is incompatible with study requirements (except if required by the Sponsor, e.g., atopic dermatitis).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Insight Research

Quatre Bornes, Mauritius, Mauritius

Countries

Mauritius

Other Identifiers

RV4620A20230438

Identifier Type: -

Identifier Source: org_study_id