Safety and Efficacy assessment of cosmetic product
- Registration Number
- CTRI/2023/10/058576
- Lead Sponsor
- Mosaic wellness pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Indian / Asian male and female subjects.
2Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4Having mild to moderate dandruff.
1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2Having refused to give his/ her assent by not signing the consent form.
3Taking part in another study is liable to interfere with this study.
4Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6Having a progressive asthma (either under treatment or last fit in the last 2 years)
7Being epileptic
8Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9Having cutaneous hypersensitivity
10Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
11Following a chronic or intermittent medicinal treatment comprising any of the following products :aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
13Having changed his/her cosmetic habits except those required by the protocol in the 3 days preceding the start of the study on the studied anatomic unit
14Having applied a hair care products and cosmetic products on the studied area the first day of the study (except hair washed with the provided neutral shampoo one day prior to the day of visit.)
15Having applied a hair care product on study visits including test products.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in dandruff after one washTimepoint: Baseline, 24 hours after application, 48 hours after application
- Secondary Outcome Measures
Name Time Method ilTimepoint: Not applicable