To understand the skin sensitivity of investigational products by assessing the irritation after patch application on healthy human volunteers

Not Applicable

Completed

Registration Number: CTRI/2012/12/003206

Lead Sponsor: Kao Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1.Subjects age group 18 - 55 years

2.Healthy male & female volunteers

3.Subjects with skin type III to V.

4.Subjects willing to give a written informed consent.

5.Subjects willing to maintain the patch test in position for 24 hours

6.Subject has not participated in a similar investigation in the past two weeks.

7.Subjects willing to come for regular follow up.

8.Subjects ready to follow instructions during the study period.

Exclusion Criteria

1.Infection, allergy on the tested area

2.History of skin allergy antecedents or atopic subjects

3.History of hyper sensitivity to any component of the tested products

4.Athletes and subjects with history of excessive sweating

5.Cutaneous disease which may influence the study result

6.Chronic illness which may influence the cutaneous state.

7.Subjects on oral corticosteroid

8.Subjects participating in any other cosmetic or therapeutic trial.

9.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: Observational

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 testTimepoint: Assessments will be done at 24 hr,48hr and after 7 days post patch application.

Secondary Outcome Measures