CTRI/2024/07/070485
Not yet recruiting
未知
Evaluation of sensitization potential of Skin Care formulations on healthy human subjects - Nil
Saffron Naturele Products Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Saffron Naturele Products Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female and male Asian Indian 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 checkup)
- •3\. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Exclusion Criteria
- •1\. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2\. Having refused to give his or 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, anti\-histamines, 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 or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
Outcomes
Primary Outcomes
Not specified
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