Pediatric Head Lice Study Product Comparison

• Sponsor: Hackensack Meridian Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02213055
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head Lice	Drug: LICEMD; Drug: Standard Head lice product	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. 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.; Other Names: Generic Name: Dimethicone
Active Comparator: 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.	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.; Other Names: permethrin (5%) malathion (0.5%) lindane (1%)

Outcome Measures

Primary Outcome Measures

1. Number of Participants Free of Live Head Lice and Free of Viable Eggs [Day after first treatment and Day 14 of study]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601

Sponsors and Collaborators

• Hackensack Meridian Health

Investigators

• Principal Investigator: Lawrence Rosen, MD, Hackensack Meridian Health
• Study Director: Jeffrey Boscamp, MD, Hackensack Meridian Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hackensack Meridian Health
• ClinicalTrials.gov Identifier: NCT02213055
• Other Study ID Numbers: Pro00000685
• First Posted: Aug 11, 2014
• Last Update Posted: Jul 29, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Hackensack Meridian Health: Lice
• Additional relevant MeSH terms: Lice Infestations; Permethrin; Malathion

Study Results

Participant Flow

Arm/Group Title	LICEMD	Standard Head Lice Product
Arm/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. 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 at seven and fourteen days 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.	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. 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 at seven and fourteen days after the first application.
Period Title: Overall Study
STARTED	97	0
COMPLETED	58	0
NOT COMPLETED	39	0

Baseline Characteristics

Arm/Group Title	LiceMD	Standard Head Lice Product	Total
Arm/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. 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 at day seven and day fourteen 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.	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. 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 at day seven and day fourteen after the first application.	Total of all reporting groups
Overall Participants	58	0	58
Age (participants) [Number]
<=18 years	58 100%	58 Infinity
Between 18 and 65 years	0 0%	0 NaN
>=65 years	0 0%	0 NaN
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	6.98 (1.73)	6.98 (1.73)
Gender (participants) [Number]
Female	45 77.6%	45 Infinity
Male	13 22.4%	13 Infinity
Region of Enrollment (participants) [Number]
United States	58 100%	58 Infinity

Outcome Measures

1. Primary Outcome

Title	Number of Participants Free of Live Head Lice and Free of Viable Eggs
Description	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.
Time Frame	Day after first treatment and Day 14 of study

Outcome Measure Data

Analysis Population Description

There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.

Arm/Group Title	LiceMD	Standard Head Lice Product
Arm/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. 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 at seven days and fourteen days 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.	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. 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 at seven days and fourteen days after the first application.
Measure Participants	58	0
Day 1 Free of live lice	57 98.3%
Day 14 Free of live lice	55 94.8%
Day 1 Free of viable eggs	32 55.2%
Day 14 Free of viable eggs	46 79.3%

Adverse Events

Time Frame	Adverse event data were collected throughout the period during which subjects were enrolled in the study, which was four years and one month.
Arm/Group Title	LiceMD		Standard Head Lice Product
Arm/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. 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 at seven and fourteen days 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.		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. 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 at seven and fourteen days after the first application.
All Cause Mortality
	LiceMD		Standard Head Lice Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LiceMD		Standard Head Lice Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	LiceMD		Standard Head Lice Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/97 (1%)		0/0 (NaN)
Skin and subcutaneous tissue disorders
Skin irritation	1/97 (1%)	1	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.