Safety and efficacy assessment of Product on ski
- Registration Number
- CTRI/2023/03/050915
- Lead Sponsor
- DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
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)Between 18 and 50 years of age.
4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5)Having all skin type.30 oily skin ,10 normal skin , 10 subjects with sensitive skin (declared through lactic acid sting
test)
1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2.Having refused to give her assent by 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)
9Having cutaneous hypersensitivity
10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
products or food products or to latex
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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6
months.
13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied
anatomic unit
14.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).
15.Do not take part in any family planning activities leading to pregnancy and breastfeeding
16.Do not take part in another study liable to interfere with this study
17.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)
18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted)
20.The day of the measurements: No test product must be used (only face cleaned with water is
accepted)
21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone
Replacement Therapy) in the past 3 months.
22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than
10 cigarettes per day) in the previous 6 months
23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
amiodarone, metals, minocycline…) in the previous 6 months
24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta
carotene…)
25.Having 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
26.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
27.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks
preceding the start of the study.
28.Having under
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in the <br/ ><br>Moisturization, pH balance, radiance and skin smoothness, Reduction in sebumTimepoint: Baseline, 30 minutes, 1 hour, 4 hours, 7 days, 14 days, 28 days
- Secondary Outcome Measures
Name Time Method Improvement in skin brightness, product safetyTimepoint: Baseline, 30 minutes, 1 hour, 4 hours, 7 days, 14 days, 28 days