NCT03973775

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Saptalis Pharmaceuticals LLC · Industry
• Sex: All
• Age: 2 Months – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Permethrin Cream 5%	Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.

Timeline

• Start date: 2018-04-10
• Primary completion: 2018-11-13
• Completion: 2018-12-06
• First posted: 2019-06-04
• Last updated: 2020-10-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study