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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.

Brief 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.

Detailed Summary:
Sponsor: bioRASI, LLC

Current Primary Outcome: Proportion of patients that are identified as cured. [ Time Frame: Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of patients that are identified as cured. [ Time Frame: Day 14 ]

Original Secondary Outcome: Same as current

Information By: bioRASI, LLC

Dates:
Date Received: November 17, 2016
Date Started: November 2016
Date Completion: September 2017
Last Updated: December 1, 2016
Last Verified: December 2016