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Completed

NCT Number: NCT07537595

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

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

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Key information

Conditions

Skin Pigmentation Healthy Volunteers Hyperpigmentation Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CIDP Biotechnology S.R.L

Bucharest, Romania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Subject having given written informed consent
  • Subjects able to read and understand study documents
  • Subjects with an official domicile
  • Subject covered by health insurance or social security
  • Female subjects of child-bearing potential using a safe method of contraception for at least 3 months prior to and throughout the study

Exclusion criteria

  • Pregnant, lactating, or planning to become pregnant during the study
  • Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study
  • Sunbed use or sun exposure of investigational zones within the 3 months prior to inclusion
  • Presence of sunburn (erythema) on the back
  • Dermatological disorders affecting investigational zones (naevi, freckles, excess hair, uneven skin tone, vitiligo, photodermatological problems)
  • History of skin cancer
  • History of abnormal response to sun
  • Presence of recent suntan or photo-test marks (per investigator opinion)
  • History of allergy, hypersensitivity, or serious reaction to any cosmetic product
  • Any concomitant medical condition that may interfere with the study (per investigator opinion)
  • Use of systemic medication for more than 5 consecutive days within the month prior to inclusion (e.g., steroids, antihistamines, antibiotics, vitamin A derivatives, psoralen)
  • Use of depigmenting, whitening or propigmenting topical treatments within the 3 months prior to inclusion
  • Physical treatment including laser or phototherapy (PUVA, IPL, PDT) within the past 6 months on investigational sites
  • Planned intensive sport (> 5 hours per week) or swimming during the study
  • Participation in another clinical study within 30 days prior to inclusion
  • Deprived of liberty by adjunction or official decision
  • Unable to be contacted by phone in case of emergency

Treatment and study plan

Treated and exposed zones (cosmetic topical products applied)

Other

exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)

Untreated and exposed zone (no product applied)

Other

exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)

Primary outcomes

  1. Skin color measurement

    Time frame: From Day 1 to Day 47

    Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and the adjacent non-exposed zone (ZNE).

Secondary outcomes

  1. Visual scoring of pigmentation

    Time frame: From Day 1 to Day 47

    Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points)

  2. Visual scoring of erythema

    Time frame: From Day 1 to Day 47

    Visual evaluation of the erythema using L'Oreal erythema scale (0-13 points)

Other outcomes

  1. Incidence of Emergent Adverse Events [Tolerability included]

    Time frame: From Day 1 to Day 47

    Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent form signature date until the end of the study.

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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