MedPath

Skin Safety Study on Healthy Human Subjects

Phase 2
Completed
Registration Number
CTRI/2017/02/007849
Lead Sponsor
Dabur India Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Subjects in age group 18 - 55 years (both the ages inclusive)

2.Healthy male & female subjects.

3.Subjects with normal Fitzpatrick skin type III to V.

4.Subjects willing to give a voluntary 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.

Exclusion Criteria

1.Infection, allergy on the tested area.

2.Skin allergy antecedents or atopic subjects.

3.Athletes and subjects with history of excessive sweating.

4.Cutaneous disease which may influence the study result.

5.Subjects on oral corticosteroid.

6.Subjects participating in any other cosmetic or therapeutic study.

7.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
Secondary Outcome Measures
NameTimeMethod
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