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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
379
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.
Universal Biopharma Reserach INC
Dinuba, California, United States
Axis Clinical Trials
Los Angeles, California, United States
LSRN Reserach
West Palm Beach, Florida, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Proportion of Index Subjects Who Are Lice-free at All Follow-up Visits Through to the Day 14 Visit.
Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.
Time frame: 14 days
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Haber Dermatology
Beachwood, Ohio, United States
McKenzie Medical Center
McKenzie, Tennessee, United States
Radiant reserach Inc.
San Antonio, Texas, United States