Trial Outcomes & Findings for Pediatric Head Lice Study Product Comparison (NCT NCT02213055)

Last Updated: 2016-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Day after first treatment and Day 14 of study

Results posted on

2016-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.
Overall Study STARTED	97	0
Overall Study COMPLETED	58	0
Overall Study NOT COMPLETED	39	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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. 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.
Overall Study Protocol was not Followed at Enrollment	5	0
Overall Study Protocol was not Followed during Study	1	0
Overall Study Documentation Issue at Enrollment	1	0
Overall Study Documentation Issue during Study	10	0
Overall Study Did not have Live Lice	8	0
Overall Study Had another Treatment during the Study	3	0
Overall Study Did not meet Inclusion Criteria	6	0
Overall Study Did not Return to School	5	0

Baseline Characteristics

Pediatric Head Lice Study Product Comparison

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LiceMD n=58 Participants 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.	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. 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 n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	58 participants n=5 Participants	—	58 participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Continuous	6.98 Years STANDARD_DEVIATION 1.73 • n=5 Participants	—	6.98 Years STANDARD_DEVIATION 1.73 • n=5 Participants
Gender Female	45 participants n=5 Participants	—	45 participants n=5 Participants
Gender Male	13 participants n=5 Participants	—	13 participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	—	58 participants n=5 Participants

PRIMARY outcome

Timeframe: Day after first treatment and Day 14 of study

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

Outcome measures

Outcome measures
Measure	LiceMD n=58 Participants 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.	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. 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.
Number of Participants Free of Live Head Lice and Free of Viable Eggs Day 14 Free of live lice	55 Participants	—
Number of Participants Free of Live Head Lice and Free of Viable Eggs Day 1 Free of viable eggs	32 Participants	—
Number of Participants Free of Live Head Lice and Free of Viable Eggs Day 1 Free of live lice	57 Participants	—
Number of Participants Free of Live Head Lice and Free of Viable Eggs Day 14 Free of viable eggs	46 Participants	—

Adverse Events

LiceMD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Head Lice Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LiceMD n=97 participants at risk 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.	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. 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.
Skin and subcutaneous tissue disorders Skin irritation	1.0% 1/97 • Number of events 1 • Adverse event data were collected throughout the period during which subjects were enrolled in the study, which was four years and one month.	— 0/0 • Adverse event data were collected throughout the period during which subjects were enrolled in the study, which was four years and one month.

Additional Information

Project Manager, Environmental Research

The Deirdre Imus Environmental Health Center at HackensackUMC

Phone: 551-996-8071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place