MedPath

To check the dermatological safety of the test products

Phase 1
Completed
Registration Number
CTRI/2023/11/060303
Lead Sponsor
ITC Life Sciences & Technology Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

1. Subjects with Fitzpatrick skin type III to V.

2. Subjects in good

health condition as per the medical screening criteria with no disease

state or physical condition that the Investigator believes could

interfere with the interpretation of the data.

3. Subject able to

read, understand and sign an appropriate informed consent form

indicating her willingness to participate.

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. Subjects with infection, allergy on the tested area.

2. Subjects with skin allergy, antecedents or atopic subjects.

3. Athletes and subjects with history of excessive sweating.

4. Subjects with cutaneous disease which may influence the study

result.

5. Subjects on oral corticosteroid.

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

7. Subjects who are currently pregnant or lactating or planning to

become pregnant in the period of study.

8. Subjects with any history of underlying uncontrolled medical

illness including diabetes, liver disease or history of alcoholism, HIV

or any other serious medical illness.

9. More than one subject selected/ participating from one family/

household.

10. Subjects working with MSCR

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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