Efficacy of Cosmetic Products in Preventing Pigmentation Induced by High Energy Visible Light (HE… (NCT07537595) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Cosmetic Products in Preventing Pigmentation Induced by High Energy Visible Light (HEVL) [400-450nm]
Romania33 participantsStarted 2024-06-10
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Caucasian subjects
✓. Male and female participants
✓. Aged between 18 and 60 years old
✓. Skin phototypes III-IV
✓. Average ITA° on the back between 18° and 35° (± 2°) at screening and baseline/inclusion visit
✓. Uniform skin color over the eight test zones (difference in ITA° between each zone ≤ 4°)
✓. Untanned back (no UV exposure - natural or artificial - during the 2 months prior to inclusion)
✓. No scar, spot, tattoo or excess hair on investigational zones
Exclusion criteria
✕. Pregnant, lactating, or planning to become pregnant during the study
✕. Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study