Safety and efficacy assessment of Product on ski
- Registration Number
- CTRI/2022/12/047808
- 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 55 years of age.
4.Skin is healthy on the studied anatomic unit
5.Presenting Fitzpatrick skin type III to V, with chromameter (ITA value) reading between -30 & 41 on cheek bones.
6.Having dull skin and uneven skin tone
7.Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas.
8.Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
9.Having visible under eye dark circle.
1.For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2.Having refused to give his/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 acne prone skin.
6.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8.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).
9.Having cutaneous hypersensitivity.
10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12.Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
13.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 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)
14.Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
15.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
16.Having consumed caffeine-based products (coffee, cola, tea, â?¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
17.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline�) in the previous 6 months
18.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ?¦)
19.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â?¦) or having applied self-tanning products in the week preceding the start of the study
20.Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
21.Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ?¦) in the 4 weeks preceding the start of the study.
22.Having a suntanned skin on the studied areas which could int
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Even skin tone, <br/ ><br>reduction in pigmentation (dark spot), radiant skin and skin brightnessTimepoint: Baseline, 14 days and 28 days
- Secondary Outcome Measures
Name Time Method ageing: minimize fine <br/ ><br>lines, smooth skin texture, reducing dark circles and improvement in skin hydrationTimepoint: Baseline, 14 days and 28 days