Pediatric Head Lice Study Product Comparison

NCT02213055 | Completed Phase 2 Results

• 1 other identifier: Pro00000685
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Lice

Keywords

Lice

Outcome Measures

Primary Outcomes (1)

• Number of Participants Free of Live Head Lice and Free of Viable Eggs

  A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.

  Day after first treatment and Day 14 of study

Study Arms (2)

LICEMD

EXPERIMENTAL

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.

Drug: LICEMD

Standard Head lice product

ACTIVE COMPARATOR

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.

Drug: Standard Head lice product

Interventions

LICEMD 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.

Also known as: Generic Name: Dimethicone

LICEMD

Standard Head lice product 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.

Also known as: permethrin (5%), malathion (0.5%), lindane (1%)

Standard Head lice product

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• 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.

  PMID: 26092045 DERIVED

MeSH Terms

Conditions

Lice Infestations

Interventions

Permethrin; Malathion; Hexachlorocyclohexane

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organothiophosphorus Compounds; Sulfur Compounds; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Project Manager, Environmental Research
• Organization: The Deirdre Imus Environmental Health Center at HackensackUMC

dimuscenter@hackensackumc.org

551-996-8071

Study Officials

• Lawrence Rosen, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

• Jeffrey Boscamp, MD

  Hackensack Meridian Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: May 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)