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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen 1 | 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). |
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| Sunscreen 2 | 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). |
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| Sunscreen 3 | 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). |
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| Untreated zone | non-treated control zone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treated zones exposed to Visible Light source | Other | The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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:
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,
Subjects having applied a local treatment on the back for more than 2 days during the 2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories, antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
Subject having antecedents of clinically significant allergy, particularly to study product components,
Subjects requiring enhanced protection (deprived of liberty, minors, under guardianship),
Subject being in a situation which, according to the Investigator, could interfere with an optimal participation in the study,
Subject currently participating or having participated in another clinical trial during the month preceding inclusion,
Subject under care of guardian or legal guardianship or subject hospitalized in a medical or social establishment for any reason,
Subject unable to communicate efficiently with the Investigator or being unable to follow the study requirements.
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie) | Nice | 06202 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40922539 | Derived | Renoux P, Jouni H, Laloux C, Touti R, Vieu DL, Lamarche F, Santos SM, Bernerd F, Marionnet C. Visible Light-Induced Pigmentation: Improved In Vivo Methodology for Measuring Efficacy of 30 Products in 9 Randomised Controlled Trials and Correlation With In Vitro Assessment. Exp Dermatol. 2025 Sep;34(9):e70167. doi: 10.1111/exd.70167. |
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| Untreated zone exposed to Visible Light source | Other | The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones. |
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| 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) | 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) | 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) | At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure). |