Pediatric Head Lice Study Product Comparison

Hackensack Meridian Health

Status and phase: Completed; Phase 2

Conditions: Head Lice

Treatments: Drug: LICEMD; Drug: Standard Head lice product

Study type: Interventional

Funder types: Other

Identifiers

NCT02213055

Pro00000685

Details and patient eligibility

About

• 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.

Full description

Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.

Enrollment: 97 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

LICEMD

Experimental group

Description:

Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.

Treatment:

Drug: LICEMD

Standard Head lice product

Active Comparator group

Description:

Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.

Treatment:

Drug: Standard Head lice product