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

This study has been completed.
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc. Identifier:
First received: July 20, 2011
Last updated: May 12, 2015
Last verified: May 2015
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
Drug: HTU-520 Patch
Other: 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
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT01400594

  Show 37 Study Locations
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
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. Identifier: NCT01400594     History of Changes
Other Study ID Numbers: HTU-520-US01
Study First Received: July 20, 2011
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Additional relevant MeSH terms:
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Tinea processed this record on November 27, 2015