Clinical Trial

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

Completed
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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
Trial Details
NCT Number NCT07537595
Lead Sponsor Cosmetique Active International
Conditions Skin Pigmentation, Healthy Volunteers, Hyperpigmentation
Enrollment 33 participants
Start Date 2024-06-10
Primary Completion 2024-12-06 (estimated)
Study Completion 2024-12-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-17