A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infest… (NCT05565820) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation
United States58 participantsStarted 2022-12-15
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of Vamousse Spray 'n' Go, compared to a 1% Permethrin control shampoo, in the treatment of head lice.
Who can participate
Age range2 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects must have an active head lice infestation defined as: at least 1 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator.
* Subjects must be at least two (2) years of age through 75 years of age, presenting with an active head lice infestation.
* Subject is male or female.
* Subject is in good general health based on medical history.
* Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children 6-17 years of age will be administered a child's Assent Form.
* The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, they must be willing and able to participate in receiving study product or Standard of Care.
* Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study.
* Following application of the test product, subject agrees not to shampoo, wash or rinse their hair or scalp until 8-hour post-treatment time has been reached and documented.
* Subject agrees not to cut or chemically treat their hair while participating in the study.
* Subject agrees to follow all study instructions, including attending all follow-up appointments.
* Female subjects of childbearing potential must …
What they're measuring
1
Proportion of Participants Who Are Completely Free of Live Lice