Evaluate the Photoprotection Efficiency of Sunscreen Formulas Under Visible Light Exposure (NCT06796088) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Photoprotection Efficiency of Sunscreen Formulas Under Visible Light Exposure
France20 participantsStarted 2020-09-23
Plain-language summary
To evaluate the protective effect of three sunscreens on the pigmentation caused by visible light in comparison to an untreated control zone in healthy volunteers.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
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
. Healthy subjects of both sexes aged 18 - 50 years old, having a phototype IIIb, IV or V according to Fitzpatrick classification,
. Subject with an ITA° (Individual Typologic Angle calculated value) between -20° and 28° at the screening visit,
. Healthy subjects based on physical examination and compatibility of medical history with the study content,
. Women of childbearing potential using adequate contraception (oral contraception, intra-uterine devices, contraceptive implants or vaginal rings, tubal sections or ligations, condoms) for at least 1 month prior to first visit and agree to continue adequate contraception during the entire duration of the study,
. Women of non-childbearing potential (menopausal with one year without bleeding, hysterectomy, bilateral ovariectomy),
. Subjects having signed a written informed consent form and dated before any study procedure began.
. Subjects willing to actively cooperate during the study duration and willing to complete the study,
. Subject affiliated to the social security system (in accordance with the French Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Exclusion criteria
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.
What they're measuring
1
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Timeframe: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
. Female who was pregnant or breast feeding or planning a pregnancy during the study,
. Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator could interfere with the interpretation of the clinical trial results such as:
. History of recurrent dermatologic conditions (e.g., psoriasis, eczema, urticaria…) or suspicion/history of allergy to cosmetics,
. Any systemic or local disease pathology
. Skin abnormality (scars, excessive hair, tattoos…) at the level of the test zones (middle part of the back),
. Subject who was overexposed to natural (sun) or artificial ultraviolet (tanning lamps) in the last month prior the first visit or who planneda such exposure during the study;
. Subject having history or presenting pathologies induced or aggravated by sun exposure or having abnormal reactions to the sun (ex : photosensitive dermatitis, polymorphic light eruption, solar urticaria, systemic erythematous lupus, dermatomyositis),
. Subject having taken a systemic treatment more than 5 days in the month preceding the inclusion (steroids, nonsteroidal anti-inflammatory drugs such as aspirin, antihistamine, insulin, hypertensors, antibiotics such as quinolones, tetracyclins, thiazids, fluoroquinolons and photosensitising treatment) or any treatment able to induce abnormal response to UV or visible light (vitamin A derivatives, psoralen, aminolevulinic acid etc.) or having plane to take these treatments during the study,