NCT03973775View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL

Enrollment

126

Participants

Timeline

Start Date

April 10, 2018

Primary Completion Date

November 13, 2018

Study Completion Date

December 6, 2018

Conditions

Scabies

Interventions

DRUG

Permethrin Cream 5%

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

Trial Locations (5)

33136

SouthCoast Research Center, Inc (Clinical Site & Drug Shipment Facility), Miami

77055

West Houston Clinical Research Service, Houston

90806

Long Beach Clinical Trials Services, Inc., Long Beach

91105

Havana Research Institute, Pasadena

93618

Universal Biopharma Research Institute Inc., Dinuba

All Listed Sponsors

collaborator

bioRASI, LLC

INDUSTRY

lead

Saptalis Pharmaceuticals LLC

INDUSTRY

NCT03973775 - A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies | Biotech Hunter | Biotech Hunter