To evaluate dermatological safety of investigational products by patch test under completeocclusion on healthy human subjects with sensitive skin type

Not Applicable

Completed

Registration Number: CTRI/2016/10/007387

Lead Sponsor: Dabur India Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

•Subjects in age group 18 - 55 years (both the ages inclusive).

•Healthy male & female subjects.

•Subjects with Fitzpatrick skin type III to V.

•Subjects willing to give a voluntary 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 from the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same.

Exclusion Criteria

•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.

•Subjects on oral corticosteroid.

•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
To evaluate the dermatological safety of the investigational products on healthy human subjects with sensitive skin typeTimepoint: Time points 0hr, 24hr and 7days post patch removal

Secondary Outcome Measures