A Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV Blue Light Induced Pigmentation and Biomarkers of Cutaneous Oxidative Stress

Part of paid clinical trials in Union, New Jersey.

Sponsor
Kenvue Brands LLC
Study ID
NCT07695753
Status
Completed

Conditions

  • Oxidative Stress
  • Pigmentation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Sunscreen application #1 — OTHER
    At Visit 1, the IPs will be applied under Condition #1. After 24 hours, the test site will be cleaned, the same IP will be reapplied directly to the test site and allowed to air dry before irradiation.
  • Sunscreen application #2 — OTHER
    At Visit 2, Sunscreen A will be applied to site 4 under Condition #2. The site will air dry before irradiation.

Study Details

To assess the level of sub pigmentation following an acute exposure to a Deep Ultraviolet A and high energy Blue Light wavelengths (380-420 nm). This study will compare the unprotected control with test products in Condition #1 and Condition #2 to assess pigmentation as well as cutaneous oxidative stress and inflammation biomarkers that occur with exposure to the same light regimen.

Key Dates

First listed
Jul 10, 2026
Start date
Oct 27, 2025
Status verified
Jul 2026
Primary completion
Dec 6, 2025
Completion
Dec 6, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: All Subjects (Condition #1)
    A trained designee will mark four test sites on the subject's back. Each test site will contain seven subsites: one on-irradiated control (subsite 1) and six subsites (subsites 2-7) designated for increasing light-radiation doses. At Visit 1, the IPs will be applied under Condition #1. Test site 1 will remain unprotected.
  • Experimental: All Subjects (Condition #2)
    At Visit 2, Sunscreen A will be applied to test site 4 under Condition #2. Test site 1 will remain unprotected.

Primary Outcome Measure

Clinical evaluation of pigmentation [ Time Frame: Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation). ]

Locations (1)

FacilityCityStateZIPSite coordinators
SGS North America, Inc. - Union Research CenterUnionNew Jersey07083-

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SGS North America, Inc. - Union Research Center· Union, NJ

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