Scabies Clinical Trial
Official title:
A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.
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.
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%.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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