NCT07194408

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: Mauritius