An observational study in Visible Light Exposures on Healthy Back Skin, sponsored by Cosmetique Active International. Completed at 1 site in Romania. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Cosmetique Active International · Observational
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.
Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy male and female volunteers from 18 to 50 years old with phototype III to IV according to the Fitzpatrick scale and with an ITA° between 18° to 32° at Screening
Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
*Effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion Criteria:
The tested product 1 was applied on 2 zones (one zone on each hemi-back), by gentle massage, according to the randomization list, 15 to 30-minutes before the Visible Light exposure. The application was done during 4 consecutive days (From Day 1 to Day 4).
Other: Visible Light Exposure - Treated zone - Left hemi-back · Other: Visible Light Exposure - Treated zone - Right hemi-back
2 non-treated control zones (one zone on each hemi-back)
Other: Visible Light Exposure - Untreated zone - Left hemi-back · Other: Visible Light Exposure - Untreated zone - Right hemi-back
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.
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)
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
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.
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