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Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis

NCT01119742 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2014-05-06

No results posted yet for this study

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

  • Interdigital Tinea Pedis

Interventions

DRUG

Butenafine Hydrochloride 1%

Twice daily application for 7 days

DRUG

Butenafine Hydrochloride 1% B

Twice daily application for 7 days

DRUG

Butenafine Hydrochloride 1%

Twice daily application for 7 days

DRUG

Vehicle A

Twice daily application for 7 days

DRUG

Vehicle B

Twice daily application for 7 days

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-03-31
Completion
2011-07-31

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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 NCT01119742 on ClinicalTrials.gov