An observational study in Study the Potency of Sunscreen to Protect Against the Pigmentation Induced by Visible Light Exposure on Healthy Back Skin, sponsored by Cosmetique Active International. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Cosmetique Active International · Observational
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.
The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation.
The aim of this study was to assess the ability of sunscreens with a protective efficacy in the UV domain to prevent the pigmentation induced by Visible Light.
Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
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Healthy male and female volunteers from 18 to 50 years old, with Phototype III to V according to the Fitzpatrick scale, with a ITA° betwwen -20° and 28° at screening
Exclusion Criteria:
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:
The test sunscreen 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).
Other: Treated zones exposed to Visible Light source
The test sunscreen 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).
Other: Treated zones exposed to Visible Light source
The test sunscreen 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4).
Other: Treated zones exposed to Visible Light source
non-treated control zone
Other: Untreated zone exposed to Visible Light source
The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones.
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Individual Typologic Angle (ITA° - calculated value)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Clinical investigator's assessment by using clinical scale
Visual scoring of pigmentation, using a pigmentation 11-point scale with 0 (No pigmentation), 1 (Doubtful), 2 (Very pale brown -), 3 (Very pale brown), 4 (Very pale brown +), 5 (Pale brown -), 6 (Pale brown), 7 (Pale brown +), 8 (Brown -), 9 (Brown), 10 (Brown +) Visual scoring of erythema, using an erythema 4-point scale with 0 (Absent), 0.5 (Doubtful), 1 (Weak but well-defined erythema), 2 (Moderate), 3 (Severe)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4, Day 5 (24 hours after each Visible Light exposure) and at Day 12..
Safety / Local Tolerance
To assess the local tolerance and the overall tolerability of the test products on the basis of undesirable effect reporting and on subjective symptoms (dryness, pruritus and burning sensation) assessed on 5-point scale from 0-4: No symptom (0); Minimal symptoms (1); Mild symptoms (2); Moderate symptoms (3); Severe symptoms (4)
Time frame: From the informed consent signature date (Screening visit) until the end of the study (Day 12).
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Pigmentation (Delta E, Delta L\* and Delta b\* - calculated values)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Erythema (Delta a\* calculated values)
Time frame: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Cosmetique Active International