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

NCT07695753 | Completed

• 1 other identifier: CS2025SK100256
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pigmentation; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation of pigmentation

  Percent mean change from baseline analysis and comparison between test sites and between subsites .

  Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation).

Secondary Outcomes (4)

• SkinColorCatch measurements

  Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation).

• Imaging of test sites

  Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation).

• Tape stripping for protein analyses

  Visit 3/Day 3 (18-22 Hours Post-Irradiation)

• Skin swabbing for cutaneous biomarkers

  Visit 3/Day 3 (18-22 Hours Post-Irradiation

Study Arms (2)

All Subjects (Condition #1)

EXPERIMENTAL

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.

Other: Sunscreen application #1

All Subjects (Condition #2)

EXPERIMENTAL

At Visit 2, Sunscreen A will be applied to test site 4 under Condition #2. Test site 1 will remain unprotected.

Other: Sunscreen application #2

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.

All Subjects (Condition #1)

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.

All Subjects (Condition #2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fitzpatrick Skin Type III or IV targeting to complete at least 5 subjects in each skin type.
• Has ITA (calculated per the method defined in ISO24442:2022) of 10.00° to 41.00° for each test site (average value from subsites 1 and 7 per site) , with no variation in ITA° greater than 5° between test sites (having uniform skin color over the whole test area).
• Agrees to receive artificial sunlight (UV) exposure on the back.
• Agrees to refrain from sun exposure on the back, use of tanning beds, and self-tanning lotions, creams, or sprays until the completion of the study.
• Generally in good health based on medical history reported by the subject.
• Able to read, write, speak, and understand English.
• Has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
• Intends to complete the study and is willing and able to follow all study instructions.

You may not qualify if:

• Has known allergies or adverse reactions to latex, common topical skincare products, UV light, or ingredients in the ISMs.
• Has a history of abnormal responses to sunlight or UV radiation.
• Has been instructed by a physician, pharmacist, or health professional to avoid sunlight because of a medical condition and/or because of drug contraindications.
• Has a history of photosensitivity (a reaction to sunlight) disorders (including solar urticaria \[hives\], phototoxicity, photo-allergy, polymorphous light eruptions).
• Is regularly taking a medication with photosensitizing potential, such as high blood pressure medication, acne medications (e.g., Accutane), certain psychiatric medications (e.g., Thorazine, tricyclic anti-depressants), certain antibiotics (e.g., Cipro, tetracycline), antihistamines (e.g., Benadryl), Levulan, or Psoralen.
• Is regularly taking other medication that could affect the results of the study (e.g., corticosteroids, steroidal or nonsteroidal anti-inflammatory drugs \[NSAIDs\], antihypertensive drugs, steroid inhalers, drugs that induce skin coloring, etc.). Low dose aspirin (≤81mg per day) is acceptable.
• Has used a tanning bed/lamp, has had extended sun exposure of the test area (the lower back), or has participated in a UV exposure study within 4 weeks before Visit 1.
• Has a concurrent illness, a medical history of a disease/condition, or a pre-existing/dormant dermatologic condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, skin infection \[fungal, bacterial, or viral\], etc.) that could interfere with the outcome of the study or increase health risk to the subject, as determined by the PI or designee.
• Via visible light and Wood's lamp evaluation: presence of sunburn, suntan, scars, tattoos, active dermal lesions, nevi, blemishes, moles, excessive tan spots from prior sunscreen testing, excessive hair, or uneven skin tone on the test area (back) that might interfere with the study.
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), and/or undergoing radiation or chemotherapy as determined by study documentation.
• Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
• Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
• Non-steroidal anti-inflammatory drugs within 5 days before Visit 1.\*
• Antihistamines within 14 days before Visit 1.\*
• Antibiotics within 16 days prior to Visit 1.\*

Sponsors & Collaborators

• Kenvue Brands LLC: lead

Study Sites (1)

SGS North America, Inc. - Union Research Center

Union, New Jersey, 07083, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 10, 2026
• Study Start: October 27, 2025
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: July 10, 2026

Record last verified: 2026-07-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)