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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

NCT03973775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2020-10-23

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • bioRASI, LLC

    collaborator INDUSTRY

  • Saptalis Pharmaceuticals LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2018-11-13
Completion
2018-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973775 on ClinicalTrials.gov