Safety testing of products by Patch Test
- Registration Number
- CTRI/2018/06/014456
- 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
1. Healthy male and female subjects in the age group of 18-55 years
(both age inclusive)
2. Subjects with Fitzpatrick skin type III to V
3. Subjects willing to give a voluntary written informed consent
4. Subjects willing to maintain the test patches in designated
positions for 24 Hours
5. Subjects having not participated in a similar investigation in the
past two weeks
6. Subjects willing to come for regular follow up visits
7. Subjects ready to follow instructions during the study period
8. Subjects without any open wounds, cuts, abrasions, irritation
symptoms
1. Subjects with Infection/ allergy/ irritation symptoms on the upper
back area identified for patch application
2. Subjects with any kind of skin allergy, antecedents or atopy or
cutaneous disease which may influence the study results
3. Subject is Pregnant or Lactating
4. Athletes and subjects with history of excessive sweating
5. Subjects on oral corticosteroid, or using any topical or systemic
medicine which might interfere with the study results
6. Subjects participating in any other cosmetic or therapeutic trial
7. Subjects with 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
Name Time Method Safety assessment of investigational products for <br/ ><br>irritation potential using Draize scale.Timepoint: Safety assessment of investigational products for <br/ ><br>irritation potential using Draize scale at 0 hour, 24 hours and Day 7 post patch removal.
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable