NCT05972434

A Study of Two Facial Sunscreens to Assess Its Effect in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity Under Controlled and Normal Conditions of Use on the Face by Adult Participants

A Single-Center, Open-Label Safety-in-Use Clinical Trial to Assess the Topical Tolerability and Efficacy in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity of Two Facial Sunscreens (IPs) Under Controlled and Normal Conditions of Use on the Face by Adult Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of 02 facial sunscreens (investigational products \[IPs\]) under controlled and normal conditions of use on the face for 28 and 56 days, respectively. This study will consist of 2 groups a) Group 1: will assess the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face in comparison with the control area (other side of face) and on the forearm, comparing 02 IPs versus control area (no product application) and 03 benchmarks; and through use of the IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, image capture (Colorface) and assessments of the efficacy perceived by the participant; b) Group 2: will evaluate the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face; and through use of IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, imaging (Colorface) and assessments of the efficacy perceived by the participant; in addition to evaluating the improvement in uniformity of facial skin tone through the use of IP under normal conditions for 56 +/- 2 days, with assessments by image analysis (Colorface), dermatological clinical analyses (radiance and homogeneity of skin tone),assessments of perceived efficacy, and emotional testimony by the participant.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Sunscreen A	Participants will apply sunscreen A topically.
OTHER	Sunscreen B	Participants will apply sunscreen B topically.

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-06-23
• Completion: 2023-07-21
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: Brazil