Safety & Efficacy assessment of eye care formulatio
- Registration Number
- CTRI/2023/06/053995
- Lead Sponsor
- Transformative Learning Solution Pvt 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 (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) Specific criteria.
4.Having wrinkles on Crows feet area with a grade of 2 (mild) to 4 (moderate) according to the Bazins Atlas.[using Page no. 40 of Skin Ageing Atlas (Scale: 0 to 6)].
5.Having under eye dark circles with grade of 4 to 7 on scale of 1-10: where 1-No dark Circle & 10-severe dark circle with larger area
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.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
7.Being epileptic.
8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9.Having cutaneous hypersensitivity
10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
11.Having known allergy to any of the Ingredient of the Test Product.
12.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)
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 the first 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 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 product than the tested products to the studied areas (only usual cleanser/soap is accepted) - The day of the measurements: No cosmetic product must be used (only face 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 a diuretic or phlebotonic treatment in the past 3 months.
19.Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
20.Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
21.Having applied products with an anti eye-bags and/or anti dark circle and/or anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid â?¦.) in the 2 weeks preceding the start of the study.
22.Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxinâ?¦) in the previous 12 months
23.Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp â?¦) in the previous year
24.Having undergone surgery of the sk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visible reduction in appearance of crowâ??s feet wrinkles & fine lines, visible reduction <br/ ><br>in appearance of under eye dark circles, improvement in skin brightness, improvement in skin firmness & improvement in skin moisturizationTimepoint: Baseline, 15 minutes after product application, 12 hours after product application, Day 14, Day 28, Day 42, Day 56
- Secondary Outcome Measures
Name Time Method ilTimepoint: Not applicable