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

NCT07194408 | Completed

• 1 other identifier: RV4620A20230438
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Global tolerance assessment by the investigator

  Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.

  At the end of the study, after Last Patient Out, (after Day 22)

Secondary Outcomes (1)

• Evaluation Global Acceptability of the Sunscreen RV4620A - RP2552

  Visit 3 (Day 22)

Study Arms (1)

Test group

Children intended to use Sunscreen RV4620A RP2552 product

Other: Sunscreen RV4620A RP2552

Interventions

Sunscreen RV4620A RP2552 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.

Test group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.

You may qualify if:

• 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 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).

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Insight Research

Quatre Bornes, Mauritius, 72218, Mauritius

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: December 12, 2023
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

MA (1)