Visible Light Exposure on Healthy Back Skin
Conditions
Keywords
pigmentation, visible light, full visible light
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.
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 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.
Interventions
Cosmetic topical products efficacy evaluation
Sponsors
L'Oreal
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin color measurement | from Day 1 to Day 47. | Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and non-exposed zone (ZNE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual scoring of pigmentation | from Day 1 to Day 47. | Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points) |
| Visual scoring of erythema | from Day 1 to Day 47. | Visual evaluation of the erythema using L'Oreal pigmentation scale (0-13 points) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | from Day 1 to Day 47. | Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent form signature date until the end of the study. |
Countries
Romania
Outcome results
None listed