CTRI/2023/02/049645
Completed
未知
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Indian male and female subjects.
- •2\)Healthy 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\)Between 18 and 35 years of age.
- •4\)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Exclusion Criteria
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2 Having refused to give her assent by not signing the consent form
- •3 Taking part in another study liable to interfere with this study
- •4 Being insulin\-dependent diabetic or non\-insulin\-dependent diabetic with a recent therapy (less than 6 months)
- •5 Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •8 Being epileptic.
- •9 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)
- •10 Having cutaneous hypersensitivity.
Outcomes
Primary Outcomes
Not specified
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