To check the effect of pollution on skin and hair on Indian women in two different cities one with polluted and other with less polluted city.
- Registration Number
- CTRI/2022/11/047496
- Lead Sponsor
- ’OREAL CHINA R&D Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Healthy female volunteer from 18 to 45 years old.
2.Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study.
3.Female of childbearing potential willing to undergo urine pregnancy test.
4.Indian skin type.
5.Average ITA° (Individual Typologic Angle calculated value) on the back between 20° and 41°.
6.Skin type III or IV according to Fitzpatrick classification.
7.Uniform skin color all over on the investigational zones on the back (difference in ITA° between each zone should not be more than 4°).
8.Absence of freckles, naevi, scars, tattoos, hairs and marks of tanning on the investigational areas on the back.
9.Subject living in the current city since at least 15 years.
10.Non-smoker subject or having stopped at least 5 years ago.
11.Subject with an indoor work activity.
12.Subject with natural hair (no coloration, no hair perm, no relaxing), from root to tip, from at least 2 years.
13.Subject having length of hair superior or equal to 15cm.
14.Subject agreeing to hair sampling randomly cut on the occipital area (about 500 hair fibers cut) for historic of exposure.
15.Subject willing and able to fulfil the study requirements and schedule.
16.Subject informed about the study objectives and procedures, and able to understand them.
17.Subject who has given written informed consent.
1.Subject who is pregnant or lactating.
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).
5.Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before screening.
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 screening 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.).
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 (antiinflammatory drugs, corticoids, retinoids, hydroquinone, etc.).
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.Subject having applied an exfoliating product on face (used, for example, for scrub, peeling, with an abrasive glove..) in the 1 week before the study.
18.Having been locked down due to COVID restrictions in the 1 year before the study.
19.Subject who declares to be deprived of freedom by administrative or legal decision.
20.Subject who cannot be contacted by telephone in case of emergency.
21.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 characterize skin and hair of Indian women living under urban pollution <br/ ><br>from a clinical, biological and instrumental point of view in comparison with a less-polluted city in similar UV <br/ ><br>exposure conditions.Timepoint: Visit 1 : Day 1(Screening and evaluation visit)
- Secondary Outcome Measures
Name Time Method The secondary objectives is to estimate the historic of exposure to global pollution through pollutants and metabolites dosage in the hair in order to preselect the most adapted subjects for a further clinical project on photo pollution impacts (study done on the back named ACR_POLLUVI 2_22-16122).Timepoint: Visit 1 : Day 1(Screening and evaluation visit)