MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT

Launched by L'OREAL · Apr 20, 2025

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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