24 hours Primary Irritation patch test on healthy human volunteers

Not Applicable

Completed

Registration Number: CTRI/2013/03/003471

Lead Sponsor: ITC RD 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 testTimepoint: To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test

Secondary Outcome Measures