At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of a 100% Dimethicone Pediculocide in School-Age Children
In Brief
A Phase 2 clinical trial evaluating LICEMD and Standard Head lice product for Head Lice. Completed, enrolled 97 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.