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: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2011

Last Updated Date

April 9, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01400594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Onychomycosis

Intervention ^ICMJE

Drug: HTU-520 patch & Placebo patch

Terbinafine hydrochloride patch

Other Name: HTU-520

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

182

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01400594

Other Study ID Numbers ^ICMJE

HTU-520-US01

Has Data Monitoring Committee

Responsible Party

Hisamitsu Pharmaceutical Co., Inc.

Study Sponsor ^ICMJE

Hisamitsu Pharmaceutical Co., Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hisamitsu Pharmaceutical Co., Inc.

Verification Date

April 2013

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

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