Head Lice Clinical Trial
Official title:
Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
- To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric
population.
- To evaluate the safety of LiceMD in a pediatric population.
Status | Completed |
Enrollment | 98 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Subject Inclusion Criteria - Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice. - Male or female child; age 3 - 12 - Willing to participate in study, and parent/guardian sign informed consent - Parent/guardian must be able to read and follow directions and complete all questionnaires - For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study. Exclusion Criteria: - No live lice, only eggs. - Less than three live lice observed with less than ten viable eggs - No hair on the head - Buzz cut or crew cut - Use of other lice treatment or home remedy lice treatment within the past 4 weeks - Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events - Currently taking an antibiotic - Does not follow instructions. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hackensack University Medical Center | Hackensack | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Hackensack University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Head Lice treatment effectiveness | A determination of head lice effectiveness will be calculated using two week post-treatment data as the primary study outcome | 2 weeks | Yes |
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