Safety & Efficacy check of cosmetic product
- Registration Number
- CTRI/2023/04/051906
- Lead Sponsor
- EMAMI LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Indian female subjects
2Healthy 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)
3Between 18 and 35 years of age.
4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
5Having dull skin with dark spots (acne PIH)
6Having under eye dark circle
7Having dark to wheatish skin (L between 45 to 55)
8Having oily to mixed oily skin type
9Having daily routine involving atleast 2 hours sun exposure
1Being 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 non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
6Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
7Following 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).
8Having cutaneous hypersensitivity.
9Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
10Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
12Refusing 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, 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)
13Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
14Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
15Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
16Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months.
17Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
18Having 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
19Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
20Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
21Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
22Refusing to follow the restrictions below during the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method moisturization, skin radiance, skin brightening, improvement in even skin toneTimepoint: Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)
- Secondary Outcome Measures
Name Time Method firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebumTimepoint: Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours)