A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Li… (NCT02060903) | Clinical Trial Compass
CompletedPhase 3
A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
United States379 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range6 Months
SexALL
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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.
What they're measuring
1
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to 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.