Safety & Efficacy assessment of skin care formulatio
- Registration Number
- CTRI/2022/12/048271
- Lead Sponsor
- Transformative Learning Solution Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1)Indian Female subjects
2)Healthy 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)
3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
4)Having crows feet wrinkles, fine lines of grade 2 - 4 & Dark spots
5)Having loose skin(face, Neck and upper arms)
1 Female subjects who are pregnant (determined by Urine pregnancy test) 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 a progressive asthma (either under treatment or last fit in the last 2 years)
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 the cosmetic products.
10 Having known allergy to any of the Ingredient of the Test Product
11 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)
12 Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
13 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
14 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
15 Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted)
16 Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding, Do not take part in another study liable to interfere with this study, Do not take 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), Do not consume any caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, During the study: Do not use other cosmetic products or skin care products other than the tested products to the studied areas. (only usual cleanser/soap is accepted), The day of the measurements : No test product must be used (only test site cleaned with water is accepted)
17 Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.
18 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
19 Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
20 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid….) in the 2 weeks preceding the start of the study.
21 Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months.
22 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in appearance of fine lines & wrinkles, Deansity of dark spots, improvement in skin moisturization,Skin firmnessTimepoint: Baseline, 15 Days, 28 Days,45 Days, 60 Days
- Secondary Outcome Measures
Name Time Method Skin safety, Improvement in skin water barrier, reduction in circumference of upper armTimepoint: Baseline, 15 Days, 28 Days,45 Days, 60 Days