24 hrs primary irritation patch test on healthy human volunteers

Not Applicable

Completed

Registration Number: CTRI/2013/05/003638

Lead Sponsor: Emami ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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 test site

•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, hypertension, 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
The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.Timepoint: The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.

Secondary Outcome Measures