Safety and efficacy assessment of Product on ski
- Registration Number
- CTRI/2023/02/049828
- Lead Sponsor
- Kama Ayurveda Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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 16 and 30 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Having oily skin & combination skin on the face.
5.Having acne prone skin.
6.Having visible pores.
7.Having mild to severe acne.
8.Having acne PIH spots.
1.For female, being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his 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 a progressive asthma (either under treatment or last fit in the last 2 years)
6.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7.Having non-stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8.Being epileptic.
9.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)
10. Having cutaneous hypersensitivity.
11.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13.Having changed her/his cosmetic habits except those required by the protocol 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. Having applied hair oil during the entire duration of the study
16.Refusing to follow the restrictions below during the study:
- For female: 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/his 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 product to the studied areas (only the usual cleanser and make-up for the lips and eyes are accepted)
- During the study: Do not use hair oil
- The day of the measurements: No test product must be used (only face cleaned with water is accepted)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Acne(lesion size & redness),reduction in Acne PIH dark spotsTimepoint: Baseline,30 minutes,1 day,3 days,7 days,14 days and 28 days
- Secondary Outcome Measures
Name Time Method Sebum reduction, visible reduction in pore size, skin smoothnessTimepoint: Baseline,30 minutes,1 day,3 days,7 days,14 days and 28 days