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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: August 18, 2014
Last verified: August 2014

July 20, 2011
August 18, 2014
July 2011
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01400594 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
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.

Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Drug: HTU-520 patch & Placebo patch
Terbinafine hydrochloride patch
Other Name: HTU-520
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.
Intervention: Drug: HTU-520 patch & Placebo patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
January 2013   (final data collection date for primary outcome measure)

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
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United States
Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
Not Provided
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
Hisamitsu Pharmaceutical Co., Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP