To check irritation potential of the given samples- Patch test
Phase 2
Completed
- Registration Number
- CTRI/2013/01/003321
- Lead Sponsor
- Wyeth Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Is a female in generally good health,Is between the ages of 14 and 18 years,Has not participated in a similar clinical investigation in the past four weeks,Is willing to give a written informed consent and come for regular observation.
Exclusion Criteria
A known history or present condition of allergic response to any cosmetic products,Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings,Medications (e.g. steroids or antihistamines), which would compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritation potentialTimepoint: On each subjectâ??s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Investigational products to be tested for irritancy testTimepoint: On each subjectâ??s back four patches of each investigational product along with positive control will be applied on Day 1. these patches will be kept for half hour, 1 hour, 2 hours and 4 hours.. After which patch will be removed and observation will be made for each patch.( i.e 0 hr observation) It will be a 4 day study. Further observations will be T 24 hrs, 48 hrs and 72 hrs <br/ ><br>