MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT (BIOVI2)

EVALUATION OF THE EFFICACY OF AN ANTIMELANOGENESIS AGENT (MELASYL) IN DIFFERENT CONCENTRATIONS UNDER PART OF VISIBLE LIGHT [400-450NM] EXPOSURES AND UNDER FULL VISIBLE LIGHT [400-700NM] EXPOSURES

The study intends to evaluate the efficacy of an anti-melanogenesis active in different concentrations under part of visible Light [400-450nm] exposures and under full visible light [400-700nm] exposures.

It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.

Study Overview

• Status: Completed
• Conditions: Visible Light Exposure on Healthy Back Skin
• Intervention / Treatment: Other: Cosmetic topical products

Detailed Description

The main objective of this study is to assess the efficacy of an anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] in healthy volunteers by skin colorimetry (Delta E).

The secondary objectives are:

• To assess the efficacy of anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] exposures in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L*, a*, b* and ITA°).
• To assess the local tolerance and safety of the topical formulations under [400-450nm] exposure and under [400-700nm] by recording adverse events and safety.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Romania
  • Budapest, Romania, 011607
    • CIDP Romania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy male and female volunteers from 18 to 65 yo, with Fitzpatrick III and IV and an ITA° between 18° to 34° at screening.

Description

Inclusion Criteria:

1. Healthy female or male volunteer from 18 to 65 years old
2. Skin type III-IV according to the Fitzpatrick classification
3. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 34° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
4. Uniform skin color over the eight zones (difference in ITA° between each zone should not be more than 4°)
5. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
6. Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
7. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
8. Subject willing and able to fulfil the study requirements and schedule
9. Subject informed about the study objectives and procedures, and able to understand them
10. Subject who has given written inform consent

Exclusion Criteria:

1. Subject who is pregnant or lactating or who is planning to become pregnant during the study
2. Subject with BMI > 30
3. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
4. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
5. Having sunburn (erythema) on the back
6. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems
7. History of skin cancer
8. History of abnormal response to sun
9. Presence of recent suntan (according to Investigator opinion) or photo-test marks
10. History of allergy, hypersensitivity, or any serious reaction to any cosmetic product
11. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
12. Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones)
13. Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivative, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study
14. Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.) or having planned to use these treatments during the study
15. Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study
16. Having planned to perform intensive sport (> 5 hours per week) or swim during the study
17. Subject who declares to be deprived of freedom by administrative or legal decision
18. Subject who cannot be contacted by telephone in case of emergency
19. Subject having participated within the 30 days before inclusion or currently participating in another clinical study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light; A total of eight (8) zones of 3x3cm will be delineated on the back, four (4) zones per hemi-back (left and right) and exposed under UVA1+physical multilayer filter cut-off wavelengths under 400nm for [400-450nm] OR exposed under full visible light for [400-700nm]. - Three (3) zones per hemi-back will be treated with topical treatments during the 7 weeks of the study: IP1: Melasyl 1% in Bright Matte (893286 03) IP2: Melasyl 0.5% in Bright Matte (893286 02) IP3: Bright Matte vehicle (893286 P) - One (1) zone per hemi-back will not be treated (control NT)

Other: Cosmetic topical products; Cosmetic topical products efficacy evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin color measurement	Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and non-exposed zone (ZNE).	from Day 1 to Day 47.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual scoring of pigmentation	Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points)	from Day 1 to Day 47.
Visual scoring of erythema	Visual evaluation of the erythema using L'Oreal pigmentation scale (0-13 points)	from Day 1 to Day 47.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment	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.	from Day 1 to Day 47.

Collaborators and Investigators

• Sponsor: L'Oreal

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pigmentation; visible light; full visible light
• Other Study ID Numbers: ACR_BIOVI2_23-02381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No