Safety Testing of cosmetic product by Patch test
- Registration Number
- CTRI/2021/04/032587
- Lead Sponsor
- Freedom Fragrances
- 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 18-45 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 a history of excessive sweating
5. Subjects on an 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 at 0 hour, 24 hours and 7 days post patch removal.Timepoint: Safety assessment of investigational products for irritation potential using draize scale.
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable