Check of safety of test product by applying patch on healthy human of different skin types
- Registration Number
- CTRI/2023/03/050596
- Lead Sponsor
- SilkLyfe
- 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 to 55 years (both age inclusive).
2. Subjects with skin phototype III to V.
3. Subjects representing normal, oily, dry and combination skin type in equal ratio.
4. Subjects willing to give a voluntary written informed consent.
5. Subjects willing to maintain the test patches in designated positions for 24 hours.
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, and 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/atopy or cutaneous disease which may influence the study results.
4. Subjects having topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
5. Athletes and subjects with history of excessive sweating.
6. Subject is pregnant or lactating.
7. Subjects 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 in the past four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to evaluate the dermatological safety of the test products by primary irritation patch test on healthy human subjects with adequate representation of varied skin typesTimepoint: Safety assessment of investigational products for <br/ ><br>irritation potential using Draize scale at Visit3 (0 hour), Visit 4 (24 hour) and visit 5 (Day 7).
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil