Pediatric Head Lice Study Product Comparison

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Treatments: Malathion; Permethrin

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.