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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01400594
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : June 4, 2015
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: HTU-520 Patch Other: Placebo Patch Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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 Name: 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 Name: Sham treatment

Primary Outcome Measures :
  1. Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail. [ Time Frame: 48 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400594

  Hide Study Locations
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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
Ameriderm Research
Ormond Beach, Florida, United States, 32174
Leavitt Medical Associates ofFL
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.
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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

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Responsible Party: Hisamitsu Pharmaceutical Co., Inc. Identifier: NCT01400594     History of Changes
Other Study ID Numbers: HTU-520-US01
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015
Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Nail Diseases
Skin Diseases