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

NCT01400594 | Completed Phase 2

• 1 other identifier: HTU-520-US01
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 37

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.

Conditions

Onychomycosis

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Determination of status with respect to complete cure (mycological cure together with clinical cure) of onychomycosis of the toenail.

  48 Weeks

Study Arms (2)

HTU-520 Patch

EXPERIMENTAL

Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.

Drug: HTU-520 Patch

Placebo Patch

PLACEBO COMPARATOR

Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.

Other: Placebo Patch

Interventions

HTU-520 Patch DRUG

Terbinafine hydrochloride patch

Also known as: HTU-520

HTU-520 Patch

Placebo Patch OTHER

Treatment with Placebo Patch

Also known as: Sham treatment

Placebo Patch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hisamitsu Pharmaceutical Co., Inc.: lead

Study Sites (37)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Radiant Research, Inc.

Birmingham, Alabama, 35209, United States

Location

UAB Department of Dermatology

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Clinical Research Advantage, Inc.

Glendale, Arizona, 85306, United States

Location

Radiant Research, Inc.

Tucson, Arizona, 85710, United States

Location

Diagnamics, Inc.

Encinatas, California, 92024, United States

Location

Radiant Research, Inc.

Denver, Colorado, 80239, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Marta Rendon, MD, Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Pab Clinical Research

Brandon, Florida, 33511, United States

Location

Dermatology Research Institute

Coral Gables, Florida, 33146, United States

Location

Ameriderm Research

Jacksonville, Florida, 32216, United States

Location

Lake Washington Foot & Ankle Center

Melbourne, Florida, 32935, United States

Location

Florida Academic Dermatology Center

Miami, Florida, 33136, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Leavitt Medical Associates ofFL

Ormond Beach, Florida, 32174, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

Radiant Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Radiant Research, Inc.

Chicago, Illinois, 60654, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Derm Research, LLC

Louisville, Kentucky, 40217, United States

Location

William P Coleman III, MD

Metairie, Louisiana, 70006, United States

Location

Callender center for Clinical Research

Glenn Dale, Maryland, 20769, United States

Location

Assoc Foot Clinic & Surgery Specialists

Flint, Michigan, 48503, United States

Location

Silverton Skin Institute

Grand Blanc, Michigan, 48439, United States

Location

University of Minnesota, Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Group Health Associates, Tri-Health

Cincinnati, Ohio, 45220, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Society Hill Dermatology

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburg Medical Center, Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Inc.

Dallas, Texas, 75231, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Coastal Podiatry Group

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 4, 2015

Record last verified: 2015-05

Locations

US (37)