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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HTU-520 Patch
Placebo Patch
Sponsored by
Hisamitsu Pharmaceutical Co., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Total Skin and Beauty Dermatology Center
  • Radiant Research, Inc.
  • UAB Department of Dermatology
  • University of Alabama at Birmingham
  • Clinical Research Advantage, Inc.
  • Radiant Research, Inc.
  • Diagnamics, Inc.
  • Radiant Research, Inc.
  • Center for Clinical and Cosmetic Research
  • Marta Rendon, MD, Skin Care Research, Inc.
  • Pab Clinical Research
  • Dermatology Research Institute
  • Ameriderm Research
  • Lake Washington Foot & Ankle Center
  • Florida Academic Dermatology Center
  • Ameriderm Research
  • Leavitt Medical Associates ofFL
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Dawes Fretzin Clinical Research Group, LLC
  • Derm Research, LLC
  • William P Coleman III, MD
  • Callender center for Clinical Research
  • Assoc Foot Clinic & Surgery Specialists
  • Silverton Skin Institute
  • University of Minnesota, Minnesota Clinical Study Center
  • Radiant Research
  • Radiant Research, Inc.
  • Group Health Associates, Tri-Health
  • Central Sooner Research
  • Society Hill Dermatology
  • University of Pittsburg Medical Center, Department of Dermatology
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Radiant Research, Inc.
  • Coastal Podiatry Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HTU-520 Patch

Placebo Patch

Arm Description

Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.

Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.

Outcomes

Primary Outcome Measures

Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2011
Last Updated
May 12, 2015
Sponsor
Hisamitsu Pharmaceutical Co., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01400594
Brief Title
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hisamitsu Pharmaceutical Co., Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTU-520 Patch
Arm Type
Experimental
Arm Description
Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.
Intervention Type
Drug
Intervention Name(s)
HTU-520 Patch
Other Intervention Name(s)
HTU-520
Intervention Description
Terbinafine hydrochloride patch
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Sham treatment
Intervention Description
Treatment with Placebo Patch
Primary Outcome Measure Information:
Title
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
Time Frame
48 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of DSO for at least one great toenail Direct microscopy of subungual debris positive for hyphal elements (KOH test) Culture confirmation of the growth of a dermatophyte Good general health Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails Willing to refrain from receiving pedicures for the duration of the study If female, using an acceptable form of birth control Exclusion Criteria: Unable to apply test product onto toenails by him/herself Use of topical antifungal agents on the nail within 1 month Uncontrolled diabetes Onychomycosis of the fingernails Confirmed non-dermatophyte infection of the target toenail Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails History of severe or chronic immunosuppression, an immunocompromised condition Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis Psoriasis of the toenails Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Sislen, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Taylor, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melanic Appell, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry I. Geisberg, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele D. Reynolds, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda P. Murray, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael P. Kyle, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth W. Dawes, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hassan Malik, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco A. Kerdel, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leon Kircik, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark S. Nestor, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas N. Robins, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pranav B. Sheth, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Throne, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick S. Agnew, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Bolshoun, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon T. Connor, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boni Elewski, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Ferris, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven E. Kempers, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel G. Lorch, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James A. Solomon, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman Bystol, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William P. Coleman, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Gillum, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William P. Jennings, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramin Farsad, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey C. Noroyan, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fredric S. Brandt, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Dunne, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marta Rendon, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimball W Silverton, DO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Tassone, DPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Total Skin and Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Radiant Research, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
UAB Department of Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinatas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Marta Rendon, MD, Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pab Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Dermatology Research Institute
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Ameriderm Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Lake Washington Foot & Ankle Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Florida Academic Dermatology Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Leavitt Medical Associates ofFL
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Radiant Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Derm Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
William P Coleman III, MD
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Callender center for Clinical Research
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
Assoc Foot Clinic & Surgery Specialists
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Silverton Skin Institute
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
University of Minnesota, Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Radiant Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Radiant Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Group Health Associates, Tri-Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Society Hill Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburg Medical Center, Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Radiant Research, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Coastal Podiatry Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23464
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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