Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, double-blind, randomized, two arm parallel design study. This study
is comprised of two phases: screening and treatment. The screening period will be up to 5
days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will
be randomized to receive either test or reference treatments in a double-blind manner in an
outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and
reference drug arms and will be stratified by site.
Screening will begin at visit 1, during which eligibility will be determined and prohibited
treatments will be discontinued. Randomization will occur following the confirmation of the
eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The
treatment phase will be 28±4 days in duration wherein subject will receive treatment with
investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and
tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and
tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day
28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the
subject will be retreated with the second application of the investigational product.