Safety and efficacy assessment of Product on ski
- Registration Number
- CTRI/2022/09/045182
- Lead Sponsor
- Kama Ayurveda Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Indian Male and 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.Between 35 and 50 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria
5.Having mild to moderate crows feet wrinkles according to the Bazins atlas. [using Page n�° 40 & 41 of Skin Ageing Atlas (Scale: 0 to 6)].
6.Having visible under eye dark circles.
7.Having under eye wrinkles of grade 2 to 4 according to the Basins atlas [ using Page n�° 46 and 47 under eye Wrinkles of Skin Ageing Atlas (Scale 0 to 8)]
8.Having visible Fine lines.
1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2Having refused to give her assent by not signing the consent form
3Taking part in another study liable to interfere with this study
4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
5Having a progressive asthma.
6Being epileptic.
7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8Having cutaneous hypersensitivity
9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10Following 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)
11Having consumed caffeine-based products (coffee, cola, tea �), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
14Having 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)
15Refusing 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 their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. Do not have acne prone skin. During the study: Do not use other cosmetic products than the tested products to the studied areas. The day of the measurements: No test product must be used (only face cleaned with water is accepted)
16Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
17Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
18Having consumed caffeine-based products (coffee, cola, tea, �), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
19Having taken a medicinal treatment which could lead to hyper pigmentation (phenyto�¯n, amiodarone, metals, minocyclineâ�¦) in the previous 6 months
20Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene�)
21Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask �) or having applied self-tanning products in the week preceding the start of the study
22Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
23Ha
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Reduction in Crow�s feet wrinkles, dark circles & improvement in skin moisturization & skin <br/ ><br>firmnessTimepoint: Baseline, Day 1, day 3 and Day 28
- Secondary Outcome Measures
Name Time Method ilTimepoint: NIl