Evaluation of safety of cosmetic product
- Registration Number
- CTRI/2022/10/046395
- 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
1Female and male Asian Indian subjects with phototype III-V.
2Healthy human 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 check-up)
3Between 18 and 65 years of age.
4Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar)
5Subjects representing sensitive skin type (as per the Baumannââ?¬•s questionnaire answered by subjects)
1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2Having eczema, psoriasis, lichen planus, vitiligo at the test site of analysis.
3Having disorder of the healing () at the test site of analysis
4Having rhinitis, allergic conjunctivitis or rhino sinusitis
5Having hypersensitivity/ allergy to any cosmetics, perfumes and/or conservatives in cosmetic products, etc.
6Having an allergy to plaster
7Having a food allergy
8Having scar excessive terminal hair or tattoo on studied area
9Having a cardiovascular pathology (taking a beta blocker treatment)
10Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. Taking a retinoid-based treatment by general or oral route
11Taking specific treatment on the back.
12Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
13Having miliaria (prickly heat) on the back.
14Presenting too many naevus on the back
15Having high pilosity on the back.
16Refusing to follow the restrictions below during the study: - During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back. - Till the follow up period of until T8 days, only use of water is acceptable from the first reading i.e., T2 days (24 hours after the patch removal). - Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches) - Do not expose the back to the sun.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs and 7 days
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil