Safety and Efficacy assessment of Product on ski
- Registration Number
- CTRI/2022/10/046399
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 35 years of age.
4 Skin is healthy on the studied anatomic unit (e.g. free of eczema, wounds, inflammatory scar)
5 Having oily or mixed oily skin type on the face (Visual assessment by dermatologist)
1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give 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 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, antihistamines, 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 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 In the previous 6 months
-Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate)
-Having taken an oral retinoid-based treatment
-Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne
17 In the previous 1 month
-Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment
-Having had an oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone
18 In the previous 2 weeks
-Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin
-Having had oral or local antibiotic treatment for acne
19 In the previous 1 week
-Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask)
-Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent reduction in total number of comedonesTimepoint: 14days, 28days
- Secondary Outcome Measures
Name Time Method Percent reduction in sebum, safety of ProductTimepoint: 14days, 28days