A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation

This was a randomized, double-blind, multicenter, vehicle-controlled, parallel-group study in subjects with active head lice infestation. The study was designed to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to scalp and hair for 10 minutes at home.

Approximately 106 index subjects with their household members were enrolled into the study. A total of approximately 318 subjects were enrolled, assuming an average of 3 members per household participating in the study.

Inclusion criteria

• Male or female, aged six months of age or older.
• Is in good general health based on medical history.
• Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
• The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
• Belongs to a household with an eligible index subject with active head lice infestation.
• Agrees to an examination for head lice and to all visits and procedures throughout the study.
• Has signed an informed consent and/or assent form.

Exclusion criteria

• Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
• Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
• Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
• Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
• Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
• Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
• Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
• Has eczema or atopic dermatitis of skin/scalp.
• Has had a prior reaction to Nix® or products containing permethrin.
• Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
• Has received an investigational agent within 30 days prior to Day 0.
• Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).