Dermatological Safety Study on Healthy Human Subjects with sensitive Ski
- Registration Number
- CTRI/2016/12/007514
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•Subjects in age group 18 -55 years
•Healthy male & female subjects
•Subjects with Fitzpatrick skin type IIIto V.
•Subjects willing to give a written informed consent.
•Subjects willing to maintain the patch test in position for 24 hours
•Subject having not participated in a similar investigation in•the past two weeks.
•Subjects willing to come for regular follow up visits.
•Subjects ready to follow instructions during the study period.
•Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-Iand by dermatological evaluation for the confirmation of the same.
•Infection, allergy on the tested area
•Skin allergy antecedents or atopic subjects
•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 more than 10 mg/day
•Subjects participating in any other cosmetic or therapeutic study.
•Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin typeTimepoint: O hr, 24 hr, 7 days
- Secondary Outcome Measures
Name Time Method Over all safety of the subjectsTimepoint: 0 hr, 24 hr, 7 days