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

NCT07537595 | Completed

• 1 other identifier: EV2404-0384 / ID24-06795
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High Energy Visible Light (HEVL)

Outcome Measures

Primary Outcomes (1)

• Skin color measurement

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

  From Day 1 to Day 47

Secondary Outcomes (2)

• Visual scoring of pigmentation

  From Day 1 to Day 47

• Visual scoring of erythema

  From Day 1 to Day 47

Other Outcomes (1)

• Incidence of Emergent Adverse Events [Tolerability included]

  From Day 1 to Day 47

Study Arms (8)

Product A

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product B

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product C

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product D

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product E

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product F

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Product G

Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47

Other: Treated and exposed zones (cosmetic topical products applied)

Control

non treated zone

Other: Untreated and exposed zone (no product applied)

Interventions

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)

Product A; Product B; Product C; Product D; Product E; Product F; Product G

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)

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy male and female volunteers from 18 to 60 yo, with Fitzpatrick III and IV and an ITA° between 18° to 35° at screening.

You may qualify if:

• Caucasian subjects
• Male and female participants
• Aged between 18 and 60 years old
• Skin phototypes III-IV
• Uniform skin color over the eight test zones (difference in ITA° between each zone ≤ 4°)
• 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

You may not qualify if:

• Pregnant, lactating, or planning to become pregnant during the study
• Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study
• 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)
• 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
• Deprived of liberty by adjunction or official decision
• Unable to be contacted by phone in case of emergency

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP Biotechnology S.R.L

Bucharest, Romania

Location

MeSH Terms

Conditions

Pigmentation Disorders; Hyperpigmentation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 17, 2026
• Study Start: June 10, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

RO (1)