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Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

NCT01580891 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1053

Last updated 2014-05-06

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.

Conditions

  • Tinea Pedis

Interventions

DRUG

Naftifine HCl Cream 1%

Naftifine HCl Cream 1% applied topically once a day for 28 days.

DRUG

Naftin® (Naftifine HCl) Cream 1%

Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.

DRUG

Placebo topical cream

Placebo topical cream applied topically once a day for 28 days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-03-31
Completion
2013-07-31

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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 NCT01580891 on ClinicalTrials.gov