MedTrace Logo

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

NCT00835510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2014-02-04

Study results available
· View outcomes & findings →

Summary

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Conditions

  • Tinea Pedis

Interventions

DRUG

Butenafine cream 1% manufactured by Taro

Treatment applied to affected area twice daily for 7 days

DRUG

Lotrimin Ultra (butenafine) 1%

Treatment applied to affected area twice daily for 7 days

DRUG

Butenafine Vehicle manufactured by Taro

Treatment applied to affected area twice daily for 7 days

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States
  • Belize

Study Locations

More Related Trials

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 NCT00835510 on ClinicalTrials.gov