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LICEMD · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| LICEMD | EXPERIMENTAL | 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. |
| Standard Head lice product | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| LICEMD | DRUG | 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. |
| Standard Head lice product | DRUG | 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. |
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 pare...
LICEMD is an investigational small molecule being developed for the treatment of head lice. It is intended for use in pediatric patients, as the clinical trial enrolled children as young as 3 years old. The drug is currently in Phase 2 clinical development.
LICEMD is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker VIVO. The company is conducting clinical research on this investigational drug for the treatment of head lice.
LICEMD is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating head lice.
LICEMD has one completed clinical trial, identified as NCT02213055, titled 'Pediatric Head Lice Study Product Comparison'. This Phase 2 study enrolled 97 participants in the United States and was an active-controlled trial, though it was not randomized or double-blinded.
No alternative names for LICEMD have been reported. The drug is known only by this name in clinical development. It is a distinct investigational small molecule being studied for the treatment of head lice.