NCT07537595

Efficacy of Cosmetic Products in Preventing Pigmentation Induced by High Energy Visible Light (HEVL) [400-450nm]

Evaluation of the Efficacy of Anti-pigmentation Agents and/or Filters Under Part of Visible Light [400-450 nm] Exposures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) \[400-450nm\] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV). The main questions it aims to answer are: Can anti-pigmentation agents and/or HEV filters reduce HEV light-induced skin pigmentation, as measured by the Individual Typological Angle (Delta ITA°)? Can these products improve additional colorimetric parameters (Delta L\*, a\*, b\*, Delta E) and clinical pigmentation and erythema scores (0-13 scale)? Are these formulations safe and well-tolerated under HEVL exposure? Researchers will compare seven cosmetic formulations (Products A to G) to an untreated exposed control zone to assess their ability to prevent HEVL-induced pigmentation. Participants will: Attend 36 visits over 7 weeks Receive standardized product applications (2 mg/cm²) on 7 test zones (3x3 cm) delineated on their back. One test zone will be not treated. Be exposed to HEVL light \[400-450nm\] at 35 J/cm² over 4 consecutive days (Days 8-11) Undergo colorimetric measurements and clinical assessments of pigmentation and erythema at 13 time points

Conditions

• Skin Pigmentation
• Healthy Volunteers
• Hyperpigmentation

Interventions

Type	Name	Description
OTHER	Treated and exposed zones (cosmetic topical products applied)	exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
OTHER	Untreated and exposed zone (no product applied)	exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Romania