Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.

Conditions

• Onychomycosis

Interventions

DRUG

HTU-520 Patch

Terbinafine hydrochloride patch

OTHER

Placebo Patch

Treatment with Placebo Patch

Sponsors & Collaborators

• Hisamitsu Pharmaceutical Co., Inc.

  lead INDUSTRY

Principal Investigators

• Donald Sislen, MD

• Susan Taylor, MD

• Melanic Appell, MD

• Harry I. Geisberg, MD

• Michele D. Reynolds, MD

• Linda P. Murray, MD

• Michael P. Kyle, MD

• Kenneth W. Dawes, MD

• Hassan Malik, MD

• Francisco A. Kerdel, MD

• Leon Kircik, MD

• Mark S. Nestor, MD

• Douglas N. Robins, MD

• Pranav B. Sheth, MD

• Martin Throne, MD

• Patrick S. Agnew, MD

• David Bolshoun, MD

• Gordon T. Connor, MD

• Boni Elewski, MD

• Laura Ferris, MD

• Steven E. Kempers, MD

• Daniel G. Lorch, MD

• James A. Solomon, MD

• Norman Bystol, MD

• William P. Coleman, MD

• Paul Gillum, MD

• William P. Jennings, MD

• Ramin Farsad, MD

• Jeffrey C. Noroyan, MD

• Fredric S. Brandt, MD

• Robert Dunne, MD

• Marta Rendon, MD

• Kimball W Silverton, DO

• John Tassone, DPM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• United States

Study Locations