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A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

Scabies Clinical Trial

Official title:
A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group, Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

Clinical Trial Summary

This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.

Clinical Trial Description

A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group Bioequivalence Study with Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of, Permethrin Cream 5% (Manufactured by Saptalis Pharmaceuticals, LLC) & Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in Subjects with Scabies. The objectives of this study are: Primary Objective: To establish the clinical bioequivalence of Permethrin Cream 5% (manufactured by Saptalis Pharmaceuticals, LLC) and Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in the treatment of scabies (Sarcoptes scabiei) following a single application. Secondary Objective: To compare the safety and tolerability between the study drugs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03973775
Study type Interventional
Source Saptalis Pharmaceuticals LLC
Contact
Status Completed
Phase Phase 3
Start date April 10, 2018
Completion date December 6, 2018
View Details
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