Pediatric Head Lice Study Product Comparison

Head Lice Clinical Trial

Official title:

Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213055
• Other study ID #: Pro00000685
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2014
• Last updated: August 8, 2014
• Start date: May 2009
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Hackensack University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Lice

Intervention

Drug:
• LICEMD
Parents/guardians of infested children will provide consent for their child's participation. 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.All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.
• Standard Head lice product
The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation,Parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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