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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT01400594
First received: July 20, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: HTU-520 patch & Placebo patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:
  • Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail. [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 182
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HTU-520 patch & Placebo patch
Subjects will receive either HTU-520 patch or placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.
Drug: HTU-520 patch & Placebo patch
Terbinafine hydrochloride patch
Other Name: HTU-520

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400594

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

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT01400594     History of Changes
Other Study ID Numbers: HTU-520-US01
Study First Received: July 20, 2011
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Onychomycosis

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014