To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators 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. This study intends to validate two simulators on visible light exposures with a referent solar formula on visible light protection.
Study Type
OBSERVATIONAL
Enrollment
15
The treated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
The treated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
The untreated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
CIDP Biotechnology S.R.L
Bucharest, Romania
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Pigmentation (Delta E - 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 at Day 12.
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Pigmentation : Individual Typologic Angle (ITA° - calculated value) based on 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 at Day 12.
Clinical investigator's assessment by using clinical scale
Visual scoring of pigmentation, using a pigmentation 14-point scale with 0 (Absence), 1 (Barely visible), 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 +), 11 (Pronouced brown -), 12 (Pronouced brown), 13 (Pronouced brown +) Visual scoring of erythema, using an erythema 14-point scale with 0 ((Absence), 1 (Barely visible), 2 (Very pale pink -), 3 (Very pale pink), 4 (Very pale pink +), 5 (Pale pink -), 6 (Pale pink), 7 (Pale pink +), 8 (Pink -), 9 (Pink), 10 (Pink +), 11 (Pronouced pink -), 12 (Pronouced pink), 13 (Pronouced pink +)
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 and Local Tolerance
Safety was assessed by recording Adverse Events, including cutaneous reactions related to Visible Light exposures or Investigational Product (local intolerance).
Time frame: From the informed consent signature date until the end of the study Day 12
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The untreated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
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.