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

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Other: Placebo Patch; Drug: HTU-520 Patch

Detailed Description

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety & Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35209
      • Radiant Research, Inc.
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center
    • Birmingham, Alabama, United States, 35233
      • UAB Department of Dermatology
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Clinical Research Advantage, Inc.
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
  • California
    • Encinatas, California, United States, 92024
      • Diagnamics, Inc.
  • Colorado
    • Denver, Colorado, United States, 80239
      • Radiant Research, Inc.
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
    • Boca Raton, Florida, United States, 33486
      • Marta Rendon, MD, Skin Care Research, Inc.
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Coral Gables, Florida, United States, 33146
      • Dermatology Research Institute
    • Jacksonville, Florida, United States, 32216
      • Ameriderm Research
    • Melbourne, Florida, United States, 32935
      • Lake Washington Foot & Ankle Center
    • Miami, Florida, United States, 33136
      • Florida Academic Dermatology Center
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates ofFL
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Radiant Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Radiant Research, Inc.
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research, LLC
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • William P Coleman III, MD
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Center For Clinical Research
  • Michigan
    • Flint, Michigan, United States, 48503
      • Assoc Foot Clinic & Surgery Specialists
    • Grand Blanc, Michigan, United States, 48439
      • Silverton Skin Institute
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • University of Minnesota, Minnesota Clinical Study Center
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Radiant Research
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc.
    • Cincinnati, Ohio, United States, 45220
      • Group Health Associates, Tri-Health
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Society Hill Dermatology
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburg Medical Center, Department of Dermatology
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75231
      • Radiant Research, Inc.
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc.
  • Virginia
    • Virginia Beach, Virginia, United States, 23464
      • Coastal Podiatry Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosis of DSO for at least one great toenail
2. Direct microscopy of subungual debris positive for hyphal elements (KOH test)
3. Culture confirmation of the growth of a dermatophyte
4. Good general health
5. Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails
6. Willing to refrain from receiving pedicures for the duration of the study
7. If female, using an acceptable form of birth control

Exclusion Criteria:

1. Unable to apply test product onto toenails by him/herself
2. Use of topical antifungal agents on the nail within 1 month
3. Uncontrolled diabetes
4. Onychomycosis of the fingernails
5. Confirmed non-dermatophyte infection of the target toenail
6. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
7. History of severe or chronic immunosuppression, an immunocompromised condition
8. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis
9. Psoriasis of the toenails
10. Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HTU-520 Patch; Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.	Drug: HTU-520 Patch; Terbinafine hydrochloride patch; Other Names: HTU-520
Placebo Comparator: Placebo Patch; Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.	Other: Placebo Patch; Treatment with Placebo Patch; Other Names: Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.	48 Weeks

Collaborators and Investigators

• Sponsor: Hisamitsu Pharmaceutical Co., Inc.
• Investigators: Principal Investigator: Donald Sislen, MD; Principal Investigator: Susan Taylor, MD; Principal Investigator: Melanic Appell, MD; Principal Investigator: Harry I. Geisberg, MD; Principal Investigator: Michele D. Reynolds, MD; Principal Investigator: Linda P. Murray, MD; Principal Investigator: Michael P. Kyle, MD; Principal Investigator: Kenneth W. Dawes, MD; Principal Investigator: Hassan Malik, MD; Principal Investigator: Francisco A. Kerdel, MD; Principal Investigator: Leon Kircik, MD; Principal Investigator: Mark S. Nestor, MD; Principal Investigator: Douglas N. Robins, MD; Principal Investigator: Pranav B. Sheth, MD; Principal Investigator: Martin Throne, MD; Principal Investigator: Patrick S. Agnew, MD; Principal Investigator: David Bolshoun, MD; Principal Investigator: Gordon T. Connor, MD; Principal Investigator: Boni Elewski, MD; Principal Investigator: Laura Ferris, MD; Principal Investigator: Steven E. Kempers, MD; Principal Investigator: Daniel G. Lorch, MD; Principal Investigator: James A. Solomon, MD; Principal Investigator: Norman Bystol, MD; Principal Investigator: William P. Coleman, MD; Principal Investigator: Paul Gillum, MD; Principal Investigator: William P. Jennings, MD; Principal Investigator: Ramin Farsad, MD; Principal Investigator: Jeffrey C. Noroyan, MD; Principal Investigator: Fredric S. Brandt, MD; Principal Investigator: Robert Dunne, MD; Principal Investigator: Marta Rendon, MD; Principal Investigator: Kimball W Silverton, DO; Principal Investigator: John Tassone, DPM

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Onychomycosis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: HTU-520-US01