CTRI/2023/11/059530
Not yet recruiting
未知
To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects. - NI
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Indian 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 40 years of age.
- •4\)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •5\)Subjects having normal eye conditions.
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 Being epileptic.
- •7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months).
- •8 Having cutaneous hypersensitivity.
- •9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •10 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).
Outcomes
Primary Outcomes
Not specified
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