MedPath

Testing Skin Safety: Checking Products on Healthy Skin with a 24-Hour Patch Test Under Cover

Phase 2
Completed
Registration Number
CTRI/2024/05/068154
Lead Sponsor
Transformative Learning Solution Pvt. Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

Subjects in age group 18 - 65 years (both the ages inclusive).

Healthy male & female subjects with skin types as defined in the

population details under appendix 1.

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.

Subject able to read,

understand and sign an appropriate informed consent form indicating

their willingness to participate.

Subjects willing to maintain the

patch test in position for 24 hours.

Subjects willing to come for

regular follow-up visits.

Subjects ready to follow instructions

during the study period.

Exclusion Criteria

Subjects with infection or any skin indications at the test area i.e.

back of the subjects.

Subjects with known history of skin allergy antecedents or atopic

subjects.

Athletes and subjects with history of excessive sweating.

Subjects with cutaneous disease which may influence the study

result.

Subjects on oral corticosteroid.

Subjects participating in any other cosmetic or therapeutic trial.

Subjects who are pregnant or nursing (self-declared).

Subjects with any history of underlying uncontrolled medical illness

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

other serious medical illness.

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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