CTRI/2022/05/042477
Completed
未知
The objective of this study will be to evaluate the sensitization potential of Skin Care formulation on healthy human subjects
Transformative Learning Solution Pvt Ltd0 sites120 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Transformative Learning Solution Pvt Ltd
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1Female and male Asian Indian subjects.
- •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 checkup).
- •3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
- •4Photo type III to V.
- •5Having apparently healthy skin on Test area.
- •6For whom the Investigator considers that the compliance will be correct.
- •7Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8Having signed a consent form.
- •9Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise saunaâ?¦) during the course of the study.
Exclusion Criteria
- •1For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2Having refused to give his/her assent by not signing the consent form
- •3Taking part in another study liable to interfere with this study
- •4Being diabetic.
- •5Being asthmatic.
- •6Following 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).
- •7Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •8Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •9Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •10Having 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
Similar Trials
Completed
Not Applicable
Evaluation of safety & Efficacy of skin care formulatioCTRI/2022/06/043455Transformative Learning Solution Pvt Ltd35
Completed
Not Applicable
Assessment of safety & Efficacy of cosmetic productCTRI/2023/02/050012Transformative Learning Solution Pvt Ltd32
Not yet recruiting
Not Applicable
Assessment of safety of cosmetic productCTRI/2023/09/057658Transformative Learning Solution Pvt Ltd
Not yet recruiting
Not Applicable
Evaluation of safety of cosmetic productCTRI/2023/06/054033Transformative Learning Solution Pvt Ltd
Completed
Not Applicable
Evaluation of safety & Efficacy of skin care formulatioCTRI/2022/05/042747Transformative Learning Solution Pvt Ltd34