NCT05168397

Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects

Evaluation of the Cutaneous and Ocular Tolerance of RV4857A Sunscreen Product and Its Efficacy Against the Recurrence of Lesions Post Sun Exposure in Subjects With Facial Acne

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure.

Detailed description

This is a monocentric study on adults and adolescents with acne prone skin on the face. This open-labelled study aim first to assess the dermatological and ophthalmological tolerance of the investigational sunscreen product RV4857A formula CD2110 after 28 days and, dermatological tolerance after 57 days of at least a twice daily on the study areas, under normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4 swimming sessions (sea or swimming pool) during at least the first month of the study. Secondary objectives : * To assess the anti-imperfection efficacy of the product during the summer * To assess the "non" rebound effect (non recurrence of acne) one month after stopping the application of the sunscreen and without any sun exposure at D85 (difference between D85 and D0) * To evaluate the impact on Quality of Life of subjects through CADI and DLQI questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed at baseline, D29 and D57 The study includes 4 visits : * Visit 1: Inclusion visit (D1) * Visit 2: Intermediate visit (D29) * Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit 4: End of study visit in autumn (D85) The theoretical study duration for each subject will be 85 days with at least 57 days of product use. The study interest areas are Face and Neck.

Conditions

• Acne

Interventions

Type	Name	Description
OTHER	RV4857A	RV4857A formula CD2110 is a sunscreen product

Timeline

• Start date: 2020-07-16
• Primary completion: 2020-11-09
• Completion: 2020-11-09
• First posted: 2021-12-23
• Last updated: 2021-12-23

Locations

1 site across 1 country: Portugal