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Efficacy of Cosmetic Products in Preventing HEVL-Induced Skin Pigmentation

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Summary

NIH registered a double-blind, randomized clinical trial (NCT07537595) evaluating the efficacy of seven anti-pigmentation cosmetic formulations in preventing skin pigmentation induced by High Energy Visible Light (HEVL, 400-450nm) in 18-60 year old Caucasian healthy volunteers. Participants will undergo 36 visits over 7 weeks with standardized product applications on delineated skin zones followed by HEVL exposure and colorimetric measurements at 13 time points.

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What changed

NIH registered a new observational clinical trial (NCT07537595) on ClinicalTrials.gov. The study will evaluate the efficacy of seven cosmetic topical products (Products A-G) in preventing skin pigmentation induced by High Energy Visible Light (HEVL, 400-450nm) at 35 J/cm². The trial will enroll healthy male and female volunteers aged 18-60 with Caucasian skin phototypes III-IV, with participants receiving standardized product applications on test zones on their back before exposure over 4 consecutive days.

This study registration provides informational notice to manufacturers of anti-pigmentation cosmetic products and clinical research organizations. No compliance obligations or regulatory deadlines are imposed by this registry entry. The findings may inform product claims and efficacy data for cosmetics manufacturers developing HEV light protection formulations.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Observational NCT07537595 Kind: OBSERVATIONAL Apr 17, 2026

Abstract

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: Treated and exposed zones (cosmetic topical products applied), Untreated and exposed zone (no product applied)

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537595

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Skin pigmentation assessment Cosmetic efficacy testing
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health

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