Topical Antifungal Treatment for Tinea Pedis

A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01396785

Enrollment

321

Registered

2011-07-19

Start date

2011-07-31

Completion date

2012-03-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Pedis

Keywords

Tinea Pedis, Antifungal

Brief summary

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.

Interventions

DRUG33525

Daily for 14 days

DRUGPlacebo

Daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderate erythema, moderate scaling, and mild pruritus

Exclusion criteria

* Pregnancy and allergies

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients achieving complete clearance	Day 42	Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary

Measure	Time frame	Description
Proportion of patients achieving effective treatment	Day 42	Clinical Cure and Mycologic Cure

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026