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: August 18, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 37 Study Locations
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: August 18, 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 September 22, 2014