To assess the safety of investigational products by assessing the irritation after patch application on human volunteers.

Not Applicable

Completed

Registration Number: CTRI/2013/01/003307

Lead Sponsor: ITC R D Centre

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test.Timepoint: 0hr post patch removal, 24hr post patch removal, and 7 Days post patch removal

Secondary Outcome Measures