CTRI/2013/03/003471
Completed
N/A
Evaluation of Dermatological safety of investigational product by primary irritation patch test on health human volunteers of varied skin types - MSCR/ITCPT/2013-01
ITC RD Centre0 sites24 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC RD Centre
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects age group 18 \- 55 years
- •Healthy male \& female volunteers
- •Subjects with skin type III to V.
- •Subjects willing to give a written informed consent.
- •Subjects willing to maintain the patch test in position for 24 hours
- •Subject has not participated in a similar investigation in the past two weeks.
- •Subjects willing to come for regular follow up.
- •Subjects ready to follow instructions during the study period.
Exclusion Criteria
- •Infection, allergy on the tested area
- •Skin allergy antecedents or atopic subjects
- •Hyper sensitivity to any component of the tested products
- •Athletes and subjects with history of excessive sweating
- •Cutaneous disease which may influence the study result
- •Chronic illness which may influence the cutaneous state.
- •Subjects on oral corticosteroid with dose 10mg/day
- •Subjects participating in any other cosmetic or therapeutic trial.
- •Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
Outcomes
Primary Outcomes
Not specified
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