Safety evaluation of cosmetic products by patch test
- Registration Number
- CTRI/2022/02/040338
- Lead Sponsor
- Arbro pharmaceutical 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
- Secondary Outcome Measures
Name Time Method