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 range18 Years – 50 Years
SexALL
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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
✕. 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:
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).
✕. 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,