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

May 12, 2015 updated by: Hisamitsu Pharmaceutical Co., Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.
Time Frame: 48 Weeks
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hisamitsu Pharmaceutical Co., Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTU-520-US01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings