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

NCT07537595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2026-04-17

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Cosmetique Active International

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537595 on ClinicalTrials.gov