To test the safety and effectiveness of products in killing lice
- Registration Number
- CTRI/2017/08/009424
- Lead Sponsor
- Dabur Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 39
1 Healthy Indian male and female subjects
2 Age from 3 to15 years (both inclusive)
3 Subjects presenting with lice infestation of
scalp and having at least five live lice and
five eggs
4 Subjects with short , medium or long length hair
5 Subjects with straight or wavy or curly hair.
6 Subject willing and capable to follow the study rules and a fixed schedule
7 Subject/ Subjectâ??s LAR able to give written informed consent and to comply with the
requirements of the study
1 Subjects not matching one of the above
mentioned inclusion criteria
2 Subject having any acute skin irritation or
diseases on the application site
3 Known hypersensitivity to any of the study
products or constituents (positive reaction
in Epicutaneous sensitivity testing)
4 Any significant medical condition or drug
history that would interfere with the study
assessments
5 Subjects with dermatological disorders which
could interfere with the evaluation of the
product tested
6 Subjects with intellectual/ mental inability
to follow study instructions (if suspected) or
incapacitation
7 Participation in any other clinical trial up
to 1 month prior to inclusion and during the
study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of anti-lice efficacy of investigational products in comparision to a already marketed product by count of lice and nymphs before and after product applicationTimepoint: T0 (before product application) & <br/ ><br>T30 (approximately 30 minutes after initiation of product application) at Day 0 and Day 10, and at <br/ ><br>a single time point on Day 5 and Day 14
- Secondary Outcome Measures
Name Time Method 1.The number of reported AE/ LI throughout the study will be used to assess the cutaneous safety and tolerance by the investigator <br/ ><br>2. Perception of efficacy, tolerance and organoleptic characteristics of the product through responses <br/ ><br>to subjective evaluation questionnaire by subjects/subjectâ??s LAR <br/ ><br>3. Count of eggs which hatch into nymphs after incubation of eggs collectedTimepoint: 1.Evaluation of number of AE/LI reported through out the study <br/ ><br>2.Subjective evaluation questionnaire by subjects/subjectâ??s LAR at Day 0 (T0 & T30min), Day 5, <br/ ><br>Day 10 (T30min) and Day 14 <br/ ><br>3.Collection of eggs at Day0T0 ,Day0T30 min,Day10T0 and Day10T30min