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BE Study of Naftifine HCL

NCT02633813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 693

Last updated 2017-05-11

No results posted yet for this study

Summary

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.

The study duration for each patient was 6 weeks: Following were the visit details.

V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Conditions

  • Tinea Pedis

Interventions

DRUG

Naftifine hydrochloride 2%

Topical application for two weeks

DRUG

Placebo

Topical application for two weeks

DRUG

Naftin® 2% (Naftifine hydrochloride 2%)

Topical application for two weeks

Sponsors & Collaborators

  • Genzum Life Sciences

    lead INDUSTRY

Principal Investigators

  • Zaidoon Al-Zubaidy · Catawba Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United States
  • Dominican Republic

Study Locations

More Related Trials

Entities

Drugs

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 NCT02633813 on ClinicalTrials.gov