To evaluate the safety of Primary Irritation Patch Test test product in healthy volunteers
Phase 4
Completed
- Registration Number
- CTRI/2022/12/048219
- Lead Sponsor
- Vasu Health Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
2.Healthy Men & women volunteers are chosen in ratio of 1:1 aged > 35 and < 60 years.
3.Having healthy skin on test area as assessed by dermatological examination and donâ??t have history of allergy.
Exclusion Criteria
1.Pregnant/nursing mothers.
2.Scars, excessive terminal hair, or tattoos on the studied area.
3.Dermatological infection/pathology on level of studied area.
4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material)
5.Chronic illness which may influence the outcome of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.1. Primary End Point: Number ofsubjects that showed no significant irritation. Score of less than or equal to 2 on the Draize scale. <br/ ><br> <br/ ><br>Timepoint: Baseline,Day1, Day 2, Day 3, Day 7 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ATimepoint: NA