Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at the study site. This study used an ex vivo method of assessment for ovicidal efficacy.

Inclusion criteria

• Healthy male or female based on medical history
• Six months of age or older.
• Has an active head lice infestation with a minimum of 3 live head lice and at least 10 undamaged and unhatched head lice eggs in their hair.
• Agrees to an examination for head lice and compliance with the study procedures.
• All adult subjects must sign a written voluntary informed consent. For minors, the parent/ legal guardian agrees to the subject participating in the study as determined by the signing of an assent of informed consent.

Exclusion criteria

• Has scalp disease or a history of allergies or prior reactions to any head lice products.
• Has a condition that, in the opinion of the Investigator, may interfere with the study.
• Is receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
• Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within 14 days prior to Day 0.
• Has received an investigational agent within 30 days prior to Day 0.