To check irritation potential of the given samples (Patch test)
Phase 2
Completed
- Registration Number
- CTRI/2014/08/004881
- Lead Sponsor
- ITC Limited Peenya Industrial Area Peenya Bangalore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1.Volunteer (female/ male) in generally good health.
2.Volunteer between the ages of 18 and 50 years.
3.Volunteer has not participated in a similar clinical investigation in the past four weeks.
4.Volunteer willing to give a written informed consent and come for regular observation.
Exclusion Criteria
1.A known history or present condition of allergic response to any cosmetic products.
2.Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
3.Medications (e.g. steroids or antihistamines), which would compromise the study.
4.Pregnant or lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method irritation potentialTimepoint: 24 hrs observation
- Secondary Outcome Measures
Name Time Method investigational products to be tested for irritancy testTimepoint: On each subject�s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).