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
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
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 Name: 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.
- Number of Participants Free of Live Head Lice and Free of Viable Eggs [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213055
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Lawrence Rosen, MD||Hackensack Meridian Health|
|Study Director:||Jeffrey Boscamp, MD||Hackensack Meridian Health|