CTRI/2023/09/057658
Not yet recruiting
未知
The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects. - Nil
Transformative Learning Solution Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Transformative Learning Solution Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
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….)
- •4 Photo type III to V.
- •5 Having apparently healthy skin on Test area.
- •6 For whom the Investigator considers that the compliance will be correct.
- •7 Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8 Having signed a consent form.
- •9 Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10 Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise sauna…) during the course of the study.
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/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.
Outcomes
Primary Outcomes
Not specified
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