V Day light exposures effects on skin pigmentation and skin quality: Comparison between Indian women from polluted ? state to less polluted ? state
- Registration Number
- CTRI/2023/07/055190
- Lead Sponsor
- ’OREAL CHINA R&D Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
1.Subject who has participated and completed in study POLLUVI 1_22-16120.
2.Healthy female volunteer from 18 to 45 years old (both inclusive).
3.Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method.
4.Female of childbearing potential willing to undergo urine pregnancy test.
5.Average ITA° (Individual Typologic Angle calculated value) on the back between 20° and 41° at Inclusion, Baseline Evaluation and UV exposure visit (D1).
6.Skin type III or IV according to Fitzpatrick classification.
7.Uniform skin color all over on the 8 investigational zones (difference in ITA° between each zone should not be more than 4°) at Inclusion, Baseline Evaluation and UV exposure visit (D1).
8.Absence of freckles, naevi, scars, tattoos, hairs and marks of tanning on the investigational area on the back.
9.Non-smoker subject or having stopped at least 5 years ago.
10.Subject with an indoor work activity.
11.Subject willing and able to fulfil the study requirements and schedule.
12.Subject informed about the study objectives and procedures, and able to understand them.
13.Subject who has given written informed consent.
1.Subject who is pregnant or lactating or who is planning to become pregnant during the study.
2.Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
3.Subject with BMI > 30.
4.Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study.
5.Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion.
6.Having sunburn (erythema) on the back.
7.Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems.
8.History of skin cancer.
9.History of abnormal response to sun.
10.Presence of recent suntan (according to Investigator opinion) or photo-test marks on back.
11.History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.
12.Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
13.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).
14.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.
15.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.
16.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.
17.Having planned to perform intensive sport ( > 5 hours per week), swim, do sauna or hammam during the study.
18.Subject who declares to be deprived of freedom by administrative or legal decision.
19.Subject who cannot be contacted by telephone in case of emergency.
20.Subject having participated within the 30 days before inclusion or currently participating in another clinical study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective of this study is to evaluate the effects of repeated UVA1 and repeated UVDL induced <br/ ><br>exposures on skin pigmentation and skin quality of urban Indian women presenting polluted ? profile versus <br/ ><br>less polluted ? profile , from a clinical, biological and instrumental point of viewTimepoint: Visit 1 (V1) at D1: Inclusion, Baseline Evaluation and UV exposure visit. <br/ ><br> Visit 2 (V2) at D2: Follow up Evaluation and UV exposure visit. <br/ ><br> Visit 3 (V3) at D3: Follow up Evaluation and UV exposure visit. <br/ ><br>Visit 4 (V4) at D4: Evaluation, UV exposure and samplings visit. <br/ ><br> Visit 5 (V5) at D5: Evaluation and samplings visit. <br/ ><br>Visit 6 (V6) at D8: Follow up evaluation visit. <br/ ><br> Visit 7 (V7) at D12: Evaluation, samplings and end of study visit. <br/ ><br>
- Secondary Outcome Measures
Name Time Method The secondary objectives are: <br/ ><br>- To compare the effects on skin pigmentation and skin quality induced with repeated UVA1 exposure versus repeated UV Day Light exposure. <br/ ><br> - To estimate the historic of exposure to global pollution through pollutants, hormones and metabolites dosage from skin and hair samplings.Timepoint: Visit 1 (V1) at D1: Inclusion, Baseline Evaluation and UV exposure visit. <br/ ><br> Visit 2 (V2) at D2: Follow up Evaluation and UV exposure visit. <br/ ><br> Visit 3 (V3) at D3: Follow up Evaluation and UV exposure visit. <br/ ><br>Visit 4 (V4) at D4: Evaluation, UV exposure and samplings visit. <br/ ><br> Visit 5 (V5) at D5: Evaluation and samplings visit. <br/ ><br>Visit 6 (V6) at D8: Follow up evaluation visit. <br/ ><br> Visit 7 (V7) at D12: Evaluation, samplings and end of study visit. <br/ ><br>