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Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

NCT01580878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2017-05-05

No results posted yet for this study

Summary

The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Conditions

  • Tinea Pedis

Interventions

DRUG

Butenafine Hydrochloride Cream, 1%

Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days

DRUG

Lotrimin Ultra®

Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.

DRUG

Butenafine Vehicle

Butenafine Vehicle applied twice daily for 7 consecutive days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Symbio CRO · http://symbioresearch.com/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-08-31
Completion
2012-12-31

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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 NCT01580878 on ClinicalTrials.gov