NCT02978508

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Mayne Pharma International Pty Ltd · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 description

Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours following dermal application. In these settings, a conventional pharmacokinetic human study to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed Drug \[RLD\] Elimite™ is not appropriate. This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w). * Test Product: Permethrin Cream, 5% * Reference Product: Elimite™ marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma. The infested person, as well as household members are treated at the same time to prevent re-infestation. In consideration of this recommendation, the household members of the enrolled subject will be examined and treated at the same time as the enrolled subject with an FDA-approved generic Permethrin Cream, 5%.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Permethrin Cream, 5%	Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
DRUG	Elimite	Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-12-01
• Last updated: 2020-09-02
• Results posted: 2020-09-02

Locations

3 sites across 1 country: United States