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24hrs skin sensitivity patch test on healthy human volunteers.

Not Applicable
Registration Number
CTRI/2017/08/009239
Lead Sponsor
Dabur India Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

•Subjects in age group 18 - 55 years

•Healthy male & female subjects

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

•Subjects willing to come for regular follow up visits.

•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

•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
NameTimeMethod
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: 0hr,24hr and 7days post patch removal
Secondary Outcome Measures
NameTimeMethod
ILTimepoint: NI
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