To evaluate the protective effect of seven 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.
Study Type
OBSERVATIONAL
Enrollment
20
The treated zones with sunscreen products were exposed to Visible Light to induce skin pigmentation (144 J/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.
CPCAD (Centre de Pharmacologie Clinique Appliquée à la Dermatologie)
Nice, France
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, Day 5 (24 hours after each Visible Light exposure) and Day 12.
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
Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance) assessed using the following 5-point score system: 0 (no sign/symptom of local intolerance); 0.5 (doubtful sign/symptom of local intolerance); 1 (mild sign/symptom of local intolerance); 2 (moderate sign/symptom of local intolerance); 3 (severe sign/symptom of local intolerance)
Time frame: From the informed consent signature date 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, Day 5 (24 hours after each Visible Light exposure) and Day 12.
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
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Erythema (Delta a\* - calculated value)
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 Day 12.