To check irritation potential of mosquito repellent wrist band.
Not Applicable
Completed
- Registration Number
- CTRI/2016/06/007025
- Lead Sponsor
- PIRAMAL HEALTHCARE LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
Volunteer ready to give written assent form,Volunteer in generally good health,Volunteer between the age group of 5 to 10 years,Volunteer has not participated in similar clinical investigation in past 1 month,Volunteer ready to keep product on test area for 72 hours.
Exclusion Criteria
1.Volunteer with known history or present condition of allergic response to any insect repellent products.
2.Volunteer with any kind of skin disease (e.g. psoriasis, atopic dermatitis) or other cutaneous manifestations on the test site, which would interfere with the test readings.
3.Volunteer on 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: day 1 band application and 30 min and 2 hr observation,day 2 24 hrs observation,day 3 48 hrs observation and day 4 72 hrs observation and band removal. day 5 24 hrs observation after band removal
- Secondary Outcome Measures
Name Time Method Investigational product to be tested for irritancy test.Timepoint: on day 1 band application on left wrist of subject.then 30 minutes, 2hrs, 24 hrs, 48 hrs and 72 hrs observation . on day 4 band removal and 24 hrs obsrevation after band removal.