Safety assessment of cosmetic product
- Registration Number
- CTRI/2023/06/053669
- Lead Sponsor
- KRIYA SKINCARE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
1) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
3) Subjects willing to come for regular follow up and ready to follow instructions during the study period.
4)10 sensitive skin volunteers (declared by lactic acid stinging test)
5)Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily,
Normal, Dry and Combination).
6) Photo type III to IV
1 For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give his/her assent by not signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being diabetic.
5 Being asthmatic.
6 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).
7 Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9 Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
10 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11 The day of the patch application: no cosmetic product must be used (test site clean with water only). Refusing to follow the restrictions below during the study: - For female: Do not become pregnant nor breastfeed. - 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, and antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
12 Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area
13 Having disorder of the healing (whatever the considered area) • Having a rhinitis, allergic conjunctivitis, or rhino sinusitis
14 Having an allergy to perfumes and/or conservatives in cosmetic products
15 Having an allergy to plaster
16 Having a food allergy
17 Having a cardiovascular pathology (taking a beta blocker treatment)
18 Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
19 Taking a retinoid-based treatment by general or oral route
20 Taking specific treatment on the back.
21 Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
22 Having miliaria (prickly heat) on the back.
23 Presenting too many naevus on the back
24 Having high pilosity on the back.
25 Refusing 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 water is accepted 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
- Secondary Outcome Measures
Name Time Method