Safety assessment of cosmetic product
- Registration Number
- CTRI/2023/07/054732
- Lead Sponsor
- TTK HEALTHCARE LIMITEDCONSUMER PRODUCT DIVISIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
1.Asian Indian male and female subjects.
2.Healthy 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)
3.Between 18 and 65 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….
1.Standard criteria
-For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
-Having refused to give his/her assent by not signing the consent form
-Taking part in another study liable to interfere with this study
-Being diabetic.
-Being asthmatic.
-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).
-Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). -Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. -Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
-Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
-The day of the patch application: no cosmetic product must be used (test site clean with water only).
2.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 anti-histamines, 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.
3.Specific criteria
- Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area
-Having disorder of the healing (whatever the considered area)
-Having a rhinitis, allergic conjunctivitis or rhino sinusitis
-Having an allergy to perfumes and/or preservatives in cosmetic products
-Having an allergy to plaster
-Having a food allergy
-Having a cardiovascular pathology (taking a beta blocker treatment)
-Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
-Taking a retinoid based treatment by general or oral route
-Taking specific treatment on the back.
-Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study
-Having miliaria (prickly heat) on the back.
-Presenting too many naevus on the back
-Having high pilosity on the back.
4. 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 Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs & 7 days
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI