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PigmentationNCT07695753

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

A study testing Sunscreen application #1 and Sunscreen application #2 in people with Pigmentation and Oxidative Stress, run by Kenvue Brands LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pigmentation, Oxidative Stress
What is being tested?
Sunscreen application #1 and Sunscreen application #2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
27 Oct 2025to 6 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.*
  • Immunosuppressive drugs or steroidal drugs within 2 months before Visit 1.*
  • Systemic or topical medication that is known to alter responses to UV radiation.* * If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the PI should be consulted to consider the impact of the specific medication on subject safety and/or the study results.
  • Has a personal or family history of skin cancer.
  • Has skeletal protrusions and/or extreme areas of curvature in the test area.
  • Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion.
  • Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study .
  • Has shaved, waxed, and/or used any hair removal method on the test area (back) within 2 weeks before visit 1.
  • Has applied any leave on product(s) on the test area within 24 hours before Visit 1.
  • Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1.
  • Has started a long-term medication within the last 2 months.
  • Has started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
  • Is an employee/contractor of the PI, Study Site, or Sponsor or immediate family member of the PI, Study Site Personnel, or Sponsor

Trial locations and contacts

1 site in 1 country.

United States1 site

  • SGS North America, Inc. - Union Research Center

    Union, New Jersey, 07083

Other trials in United States

About this study

Official title: A Single Center, Controlled 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

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.

Being tested
Sunscreen application #1, Sunscreen application #2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sunscreen application #1Other

    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 #2Other

    At Visit 2, Sunscreen A will be applied to site 4 under Condition #2. The site will air dry before irradiation.

Study groups in NCT07695753
Study groupRoleWhat they receive
All Subjects (Condition #1)ExperimentalA 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.
Receives: Other: Sunscreen application #1
All Subjects (Condition #2)ExperimentalAt Visit 2, Sunscreen A will be applied to test site 4 under Condition #2. Test site 1 will remain unprotected.
Receives: Other: Sunscreen application #2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical evaluation of pigmentation

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

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

Secondary outcomes (4)

  1. SkinColorCatch measurements

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

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

  2. Imaging of test sites

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

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

  3. Tape stripping for protein analyses

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

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

  4. Skin swabbing for cutaneous biomarkers

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start27 Oct 2025
  3. Primary completion6 Dec 2025
  4. Study completion6 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07695753
Sponsor's protocol ID
CS2025SK100256
Status last verified
6 Jul 2026
First submitted
11 Jun 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sunscreen application #1 and Sunscreen application #2 in people with Pigmentation and Oxidative Stress, run by Kenvue Brands LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07695753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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