Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
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|ClinicalTrials.gov Identifier: NCT02978508|
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : November 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Scabies||Drug: Permethrin Cream, 5% Drug: Elimite||Phase 3|
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%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Permethrin Cream, 5%
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
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.
Active Comparator: Elimite
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
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.
Other Name: Permethrin Cream, 5%
- Proportion of patients that are identified as cured. [ Time Frame: Day 28 ]To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
- Proportion of patients that are identified as cured. [ Time Frame: Day 14 ]To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
- Safety Variable [ Time Frame: Day 28 ]Analysis of safety variables will be based on all adverse event (AE) capture measuring severity and duration.
- Tolerability Assessment [ Time Frame: Day 1, Day 7, Day 14, Day 28 ]Analysis of tolerability will be based on scores of Stinging/Burning and Itching sensations collected during Patient Self-Assessments at visits 2-5 between the test and reference treatment groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978508
|United States, Florida|
|LCC Medical Research Institute|
|Miami, Florida, United States, 33126|
|Southcoast Research Center|
|Miami, Florida, United States, 33136|
|United States, Washington|
|Mid Columbia Research|
|Richland, Washington, United States, 99352|
|Study Director:||Phoevos Hughes, JD||bioRASI, LLC|