Status:
COMPLETED
MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT
Lead Sponsor:
L'Oreal
Conditions:
Visible Light Exposure on Healthy Back Skin
Eligibility:
All Genders
18-65 years
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 \[400-700nm\] ex...
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 sk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06937515
Start Date
March 27 2023
End Date
September 1 2023
Last Update
April 22 2025
Active Locations (1)
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1
CIDP Romania
Budapest, Romania, 011607