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Trial record 10 of 10 for:    Malathion

Pediatric Head Lice Study Product Comparison

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ClinicalTrials.gov Identifier: NCT02213055
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head Lice
Interventions Drug: LICEMD
Drug: Standard Head lice product
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LICEMD Standard Head Lice Product
Hide 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
Reason Not Completed
Protocol was not Followed at Enrollment             5             0
Protocol was not Followed during Study             1             0
Documentation Issue at Enrollment             1             0
Documentation Issue during Study             10             0
Did not have Live Lice             8             0
Had another Treatment during the Study             3             0
Did not meet Inclusion Criteria             6             0
Did not Return to School             5             0
Arm/Group Title LiceMD Standard Head Lice Product Total
Hide 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 Number of Baseline Participants 58 0 58
Hide Baseline Analysis Population Description
There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 0 participants 58 participants
<=18 years 58 58
Between 18 and 65 years 0 0
>=65 years 0 0
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 0 participants 58 participants
6.98  (1.73) 6.98  (1.73)
[1]
Measure Description: There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 0 participants 58 participants
Female 45 45
Male 13 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 0 participants 58 participants
58 58
1.Primary Outcome
Title Number of Participants Free of Live Head Lice and Free of Viable Eggs
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.
Arm/Group Title LiceMD Standard Head Lice Product
Hide 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.

Overall Number of Participants Analyzed 58 0
Measure Type: Number
Unit of Measure: Participants
Day 1 Free of live lice 57
Day 14 Free of live lice 55
Day 1 Free of viable eggs 32
Day 14 Free of viable eggs 46
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LiceMD Standard Head Lice Product
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LiceMD Standard Head Lice Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/97 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LiceMD Standard Head Lice Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/97 (1.03%)      0/0    
Skin and subcutaneous tissue disorders     
Skin irritation  [1]  1/97 (1.03%)  1 0/0  0
Indicates events were collected by systematic assessment
[1]
School nurse transcribed adverse event (reported by parent/guardian), as “Irritation on cheek at time of shampoo application” which occurred “10 min after shampoo was washed off.” Irritation lasted 10 minutes and no medical attention was needed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Project Manager, Environmental Research
Organization: The Deirdre Imus Environmental Health Center at HackensackUMC
Phone: 551-996-8071
Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02213055     History of Changes
Other Study ID Numbers: Pro00000685
First Submitted: August 7, 2014
First Posted: August 11, 2014
Results First Submitted: March 30, 2016
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016