Evaluation of dermatological safety of investigational products by pasting patch on the upper back of healthy human volunteers.
- Registration Number
- CTRI/2012/01/002342
- Lead Sponsor
- ITC RD Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by dermatological visual assessment.Timepoint: 0HRS, 24HRS, 1WEEK ASSESSMENT
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable