Phase 2 N=97 Treatment

Pediatric Head Lice Study Product Comparison

Head Lice

Bottom Line

View on ClinicalTrials.gov: NCT02213055 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Number of Participants Free of Live Head Lice and Free of Viable Eggs — 57; 55; 32; 46 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LICEMD (Drug); Standard Head lice product (Drug)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: Hackensack Meridian Health
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Free of Live Head Lice and Free of Viable Eggs	57; 55; 32; 46	—

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.

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.

View full record on ClinicalTrials.gov →

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.