In-Use Tolerance & Efficacy Study Under Dermatological Control of Sunscreen in Adults With Atopic Dermatitis Skin

NCT07194421 | Completed

• 1 other identifier: RV4620A20230439
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a broad-spectrum SPF50+ sunscreen on 42 adults with Atopic Dermatitis, measuring skin tolerance and barrier function. The study includes several visits as follow :

• Visit 1: Inclusion (Day 1)
• Visit 2: Intermediate Visit (Day 8)
• Visit 3: End of Study (Day 22)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Global tolerance assessment by the investigator

  Global tolerance of the product is assessed on the "tolerance population" which includes all the subjects who applied investigational product at least once. 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 (5)

• Evaluation Cosmetic Acceptability of the Sunscreen RV4620A - RP2552

  Visit 3 (Day 22)

• Evaluation of Irritative Factors with Sunscreen RV4620A - RP2552

  Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)

• Evaluation of Transepidermal Water Loss with Sunscreen RV4620A - RP2552

  Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)

• Assessment of Skin pH with Sunscreen RV4620A - RP2552

  Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)

• Assessment of the Lipidic Index Evolution with Sunscreen RV4620A - RP2552

  Visit 1 (Day 1, before investigational product application) and Visit 3 (Day 22)

Study Arms (1)

Test group

Adult 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: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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:

• Phototype: from I to VI.
• Sun Exposure: Adults anticipating at least 6 exposures of 2 hours each during the study.
• Swimming Sessions: Subjects planning at least 4 swimming sessions, with a minimum of 50% intending to swim twice in the sea and twice in a pool.
• Sensitive Skin: At least 50% of subjects report having sensitive skin.
• Health Insurance: Must be registered with health social security or health insurance.
• Informed Consent: Must have signed the written Informed Consent form (ICF) for study participation.
• Personal Information: Must certify the accuracy of personal information provided to the Investigator.
• Health Status: Considered a "healthy subject" by the Investigator (excluding SCORAD considerations).
• Criteria Related to Skin Condition:
• 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.
• Reactivity: Must be reactive to external irritative factors such as chlorine, sand, salt, and sweat.
• 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.

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: October 10, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

MA (1)