A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Intervention: Abametapir Lotion 0.74% w/w; Vehicle Lotion
Intervention description: Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.; Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 379.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Head Lice; Hatchtech

Summary:

      The purpose of the study was 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 the
      scalp and hair for 10 minutes at home.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, aged six months of age or older.

          2. Is in good general health based on medical history.

          3. 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.

          4. The subject and/or their caregiver is physically able and willing to apply the
             Investigational Product at home.

          5. Belongs to a household with an eligible index subject with active head lice
             infestation.

          6. Agrees to an examination for head lice and to all visits and procedures throughout the
             study.

          7. Has signed an informed consent and/or assent form.

        Exclusion Criteria:

          1. Had treatment (over-the-counter ), home remedy or prescription medication) for head
             lice within 14 days prior to Day 0.

          2. 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.

          3. Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as
             rescue therapy to this Protocol.

          4. Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from
             Day 0 through the Day 14 visit.

          5. Has a household member(s) who is infested with lice but is not willing or not eligible
             for enrollment.

          6. Has a condition that, in the opinion of the Investigator, may increase the risk to the
             subject and/or the interpretation of the data.

          7. 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.

          8. Has eczema or atopic dermatitis of skin/scalp.

          9. Has had a prior reaction to Nix® or products containing permethrin.

         10. Receiving systemic or topical medication, which in the opinion of the Investigator,
             may compromise the integrity of the safety and/or efficacy assessments.

         11. Has received an investigational agent within 30 days prior to Day 0.

         12. 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).