Safety testing of cosmetic products through patch test
- Registration Number
- CTRI/2017/07/009009
- 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 irritational potential using Draize scoreTimepoint: Draize Scoring to be done at 0 hrs, 24 hrs and day 7 of patch removal
- Secondary Outcome Measures
Name Time Method 0 hour, 24 hour and 7 day post patch removal reading using draize scoreTimepoint: 0 hour, 24 hour and 7 day