MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT

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.

Inclusion criteria

• Healthy female or male volunteer from 18 to 65 years old
• Skin type III-IV according to the Fitzpatrick classification
• 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
• 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

Exclusion criteria

• 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 used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
• 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 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)
• 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
• 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
• 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
• Subject having participated within the 30 days before inclusion or currently participating in another clinical study