MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT

NCT06937515 | Completed

• 1 other identifier: ACR_BIOVI2_23-02381
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visible Light Exposure on Healthy Back Skin

Keywords

pigmentation; visible light; full visible light

Outcome Measures

Primary Outcomes (1)

• 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 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)

• Safety assessment

  from Day 1 to Day 47.

Study Arms (1)

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

Interventions

Cosmetic topical products OTHER

Cosmetic topical products efficacy evaluation

Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthy female or male volunteer from 18 to 65 years old
• Skin type III-IV according to the Fitzpatrick classification
• Uniform skin color over the eight zones (difference in ITA° between each zone should not be more than 4°)
• Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
• 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)
• Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
• Subject willing and able to fulfil the study requirements and schedule
• Subject informed about the study objectives and procedures, and able to understand them
• Subject who has given written inform consent

You may not qualify if:

• Subject who is pregnant or lactating or who is planning to become pregnant during the study
• Subject with BMI \> 30
• Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
• Having sunburn (erythema) on the back
• Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems
• History of skin cancer
• History of abnormal response to sun
• Presence of recent suntan (according to Investigator opinion) or photo-test marks
• History of allergy, hypersensitivity, or any serious reaction to any cosmetic product
• Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
• 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
• Having planned to perform intensive sport (\> 5 hours per week) or swim during the study
• Subject who declares to be deprived of freedom by administrative or legal decision
• Subject who cannot be contacted by telephone in case of emergency

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

CIDP Romania

Budapest, 011607, Romania

Location

Related Publications (1)

• Piffaut V, De Dormael R, Belaidi JP, Bertrand L, Passeron T, Bernerd F, Marionnet C. Topical prevention from high energy visible light-induced pigmentation by 2-mercaptonicotinoyl glycine, but not by ascorbic acid antioxidant: 2 randomized controlled trials. Front Pharmacol. 2025 Oct 9;16:1651068. doi: 10.3389/fphar.2025.1651068. eCollection 2025.

  PMID: 41142247 DERIVED

Study Design

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

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 22, 2025
• Study Start: March 27, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)