Phase 2
Completed N=97
Pediatric Head Lice Study Product Comparison
Head Lice
Source: ClinicalTrials.gov NCT02213055 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants Free of Live Head Lice and Free of Viable Eggs — 57; 55; 32; 46 Participants
Summary
* 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free of Live Head Lice and Free of Viable Eggs |
57; 55; 32; 46 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02213055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.