A Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV… (NCT07695753) | Clinical Trial Compass
CompletedNot Applicable
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
United States22 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.