Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

Conditions
Scabies
Interventions
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.

DRUG

Elimite

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.

Trial Locations (3)

33126

LCC Medical Research Institute, Miami

33136

Southcoast Research Center, Miami

99352

Mid Columbia Research, Richland

All Listed Sponsors
collaborator

bioRASI, LLC

INDUSTRY

lead

Mayne Pharma International Pty Ltd

INDUSTRY

NCT02978508 - Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies. | Biotech Hunter | Biotech Hunter