safety testing of cosmetic soap by patch test
- Registration Number
- CTRI/2021/07/034712
- Lead Sponsor
- Asclepius Wellness Pvt Ltd
- 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. Subject is having valid proof of identity and age
3. Subjects with skin phototype III to V
4. Subject is having apparently healthy skin on test area
5. Subject representing normal, oily, dry and combination skin type in nearly
equal ratio
6. Subject willing to give a voluntary written informed consent
7. Subject willing to maintain the test patches in designated positions for 24
Hours
8. Subject willing to come for regular follow up visits
9. Subject ready to follow instructions during the study period
10. Subject without any open wounds, cuts, abrasions, irritation symptoms
1. Subjects with Known hypersensitivity to any of the study products or constituents
2. Subjects having any significant pathology in the test area
3. Subjects with any kind of skin allergy, antecedents or cutaneous disease which may
influence the study results
4. Subjects having topical or systemic treatment in last month prior to participation in the
study and during the study that could interfere with the study treatments/ assessments
5. Athletes and subjects with history of excessive sweating
6. Subject is Pregnant or Lactating
7. Subject with any significant medical condition that would interfere with the
participation in the trial
8. Subjects participated in any other cosmetic or therapeutic trial or in a similar
investigation
9. Subject is having Scars, excessive terminal hair or tattoo on the studied area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of investigational products for irritation potential using Draize scale at 0 hours,24 hours and 7 days post patch removal.Timepoint: 0 hours,24 hours and 7 days post patch removal
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable