Evaluation of safety & Efficacy of cosmetic product
- Registration Number
- CTRI/2023/10/058850
- Lead Sponsor
- GLENMARK PHARMACEUTICALS LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Indian Female subjects
2.Healthy subjects
3.Age 18 years and above (up to 60 years).
4.Skin is healthy on the studied anatomic unit
5.Human subjects with melasma
1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2.Having refused to give her assent by not signing the consent form.
3.Taking part in another study liable to interfere with this study.
4.Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5.Having progressive asthma.
6.Being epileptic.
7.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8.Having cutaneous hypersensitivity
9.Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
10.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11.Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements.
12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
14.Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Melasma reductionTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 112
- Secondary Outcome Measures
Name Time Method Change in quality of lifestyle related to melasma and number of Events, cosmetic acceptibility, reduction in melanin content of pigmentary spotsTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 112