Pediatric Head Lice Study Product Comparison

NCT ID: NCT02213055

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-08-31

Brief 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.

Detailed 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.

Conditions

Head Lice

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LICEMD

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.

Group Type: EXPERIMENTAL

LICEMD

Intervention Type: DRUG

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. 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

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.

Group Type: ACTIVE_COMPARATOR

Standard Head lice product

Intervention Type: DRUG

The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments 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 examination, the school nurse will instruct the parent/guardian to retreat.

Interventions

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. 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.

Intervention Type: DRUG

Standard Head lice product

The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments 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 examination, the school nurse will instruct the parent/guardian to retreat.

Intervention Type: DRUG

Other Intervention Names

Generic Name: Dimethicone; permethrin (5%); malathion (0.5%); lindane (1%)

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Jeffrey Boscamp, MD

Role: STUDY_DIRECTOR

Hackensack Meridian Health

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

References

Ihde ES, Boscamp JR, Loh JM, Rosen L. Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr. 2015 Jun 20;15:70. doi: 10.1186/s12887-015-0381-0.

Reference Type: DERIVED

PMID: 26092045 (View on PubMed)

Other Identifiers

Pro00000685

Identifier Type: -

Identifier Source: org_study_id