ANTIPIGMENTING OR DEPIMENTING EFFICACY UNDER PART OF VISIBLE LIGHT

NCT ID: NCT06945393

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-21
• Study Completion Date: 2022-05-21

Brief Summary

The study intends to validate a protocol and define a positive reference to evaluate the efficacy of anti-pigmenting and depigmenting agents under part of visible Light exposures, between 400nm to 450nm.

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.

Detailed Description

The main objective of this study is to assess the efficacy of antipigmenting or depigmenting agents under [400-450nm] exposure in healthy volunteers by skin colorimetry (Delta E).

The secondary objectives are:

• To assess the efficacy of antipigmenting or depigmenting agents under [400-450nm] exposure in healthy volunteers by clinical evaluation and additional colorimetry measurements (Delta L*, a*, b* and ITA°) and clinical evaluation.
• To assess the local tolerance and safety of the topical formulations under [400-450nm] exposure by recording adverse events and safety.

Conditions

Visible Light Exposure on Healthy Back Skin

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

4 differents actives compare to its respective vehicle

8 topical cosmetics formulae applied on the back of volunteers, in mini-zones about 9cm2, at 4mg/cm2. Applied twice daily during 46 days: T1: Kopcinol 5% in inverse silicon T2: Vitamin C 7% in inverse silicon T3: Thiopyridinone 1% in Bright Matte T4: CD7414 0.5% in Hydro Alcoholic gel T5: Vehicle Inverse silicon T6: Hydro Alcoholic gel vehicle T7: Bright Matte vehicle

Cosmetic topical products

Intervention Type: OTHER

Cosmetic topical products efficacy evaluation

Interventions

Cosmetic topical products

Cosmetic topical products efficacy evaluation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy female or male volunteer from 18 to 50 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 32° 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

L'Oreal

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIDP Roumania

Bucharest, , Romania

Countries

Romania

References

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.

Reference Type: DERIVED

PMID: 41142247 (View on PubMed)

Other Identifiers

L'Oréal

Identifier Type: -

Identifier Source: org_study_id