Skin Safety Study on Healthy Human Subjects

Not Applicable

Completed

• Registration Number: CTRI/2017/08/009257
• Lead Sponsor: Dabur India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-05-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1 Subjects in age group 18 -55 years

2 Healthy male and female subjects

3 Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks

7 Subjects willing to come for regular follow up visits

8 Subjects ready to follow instructions during the study period

9 Subjects with sensitive skin type as per the score obtained on the skin type identification questionnaire in annexure-I and by dermatological evaluation for the confirmation of the same

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

•Subjects participating in any other cosmetic or therapeutic study.

•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
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin typeTimepoint: Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin type

Secondary Outcome Measures

Name	Time	Method
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects with sensitive skin typeTimepoint: 9 days