Bio-equivalence Study Comparing Permethrin Cream 5% With Elimite in Patients With Active Scabies.

  • STATUS
    Not Recruiting
  • participants needed
    140
  • sponsor
    bioRASI, LLC
Updated on 25 January 2021

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.

Details
Condition Scabies
Treatment Permethrin Cream, 5%, Elimite
Clinical Study IdentifierNCT02978508
SponsorbioRASI, LLC
Last Modified on25 January 2021

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