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Closed Patch Test (24 hrs)to assess dermatological safety of test products.

Not Applicable
Completed
Registration Number
CTRI/2013/03/003474
Lead Sponsor
ITC R D Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

Subject age group 18-55 years.

-Healthy Male and Female Volunteers.

-Subject with skin type III and IV.

-Subject willing to give a written Informed consent.

-Subject willing to maintain the patch test in position for 24 hrs.

-Subject has not participated in similar investigation in the past two weeks.

-Subject willing to come for regular follow up.

-Subject ready to follow instructions during the study period.

Exclusion Criteria

-Infection, Allergy on 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 with dose 10mg/day.

-Subjects participating in any other cosmetic or therapeutic trial.

-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
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch test.Timepoint: 9 Days for each subject.
Secondary Outcome Measures
NameTimeMethod
ILTimepoint: NI
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