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Completed

NCT Number: NCT01396785

Topical Antifungal Treatment for Tinea Pedis

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

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cidra, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion criteria

  • Pregnancy and allergies

Treatment and study plan

33525

Drug

Daily for 14 days

Placebo

Drug

Daily for 14 days

Primary outcomes

  1. Proportion of patients achieving complete clearance

    Time frame: Day 42

    Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary outcomes

  1. Proportion of patients achieving effective treatment

    Time frame: Day 42

    Clinical Cure and Mycologic Cure

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2011
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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