Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.

Not Applicable

Completed

• Registration Number: CTRI/2011/12/002239
• Lead Sponsor: ITC RD Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

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