Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
NCT ID: NCT01400594
Last Updated: 2015-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2011-07-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HTU-520 Patch
Subjects will receive HTU-520 patch in a 1:1 ratio for 48 weeks applied to all toenails.
HTU-520 Patch
Terbinafine hydrochloride patch
Placebo Patch
Subjects will receive placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.
Placebo Patch
Treatment with Placebo Patch
Interventions
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HTU-520 Patch
Terbinafine hydrochloride patch
Placebo Patch
Treatment with Placebo Patch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
70 Years
ALL
No
Sponsors
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Hisamitsu Pharmaceutical Co., Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Sislen, MD
Role: PRINCIPAL_INVESTIGATOR
Susan Taylor, MD
Role: PRINCIPAL_INVESTIGATOR
Melanic Appell, MD
Role: PRINCIPAL_INVESTIGATOR
Harry I. Geisberg, MD
Role: PRINCIPAL_INVESTIGATOR
Michele D. Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
Linda P. Murray, MD
Role: PRINCIPAL_INVESTIGATOR
Michael P. Kyle, MD
Role: PRINCIPAL_INVESTIGATOR
Kenneth W. Dawes, MD
Role: PRINCIPAL_INVESTIGATOR
Hassan Malik, MD
Role: PRINCIPAL_INVESTIGATOR
Francisco A. Kerdel, MD
Role: PRINCIPAL_INVESTIGATOR
Leon Kircik, MD
Role: PRINCIPAL_INVESTIGATOR
Mark S. Nestor, MD
Role: PRINCIPAL_INVESTIGATOR
Douglas N. Robins, MD
Role: PRINCIPAL_INVESTIGATOR
Pranav B. Sheth, MD
Role: PRINCIPAL_INVESTIGATOR
Martin Throne, MD
Role: PRINCIPAL_INVESTIGATOR
Patrick S. Agnew, MD
Role: PRINCIPAL_INVESTIGATOR
David Bolshoun, MD
Role: PRINCIPAL_INVESTIGATOR
Gordon T. Connor, MD
Role: PRINCIPAL_INVESTIGATOR
Boni Elewski, MD
Role: PRINCIPAL_INVESTIGATOR
Laura Ferris, MD
Role: PRINCIPAL_INVESTIGATOR
Steven E. Kempers, MD
Role: PRINCIPAL_INVESTIGATOR
Daniel G. Lorch, MD
Role: PRINCIPAL_INVESTIGATOR
James A. Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Norman Bystol, MD
Role: PRINCIPAL_INVESTIGATOR
William P. Coleman, MD
Role: PRINCIPAL_INVESTIGATOR
Paul Gillum, MD
Role: PRINCIPAL_INVESTIGATOR
William P. Jennings, MD
Role: PRINCIPAL_INVESTIGATOR
Ramin Farsad, MD
Role: PRINCIPAL_INVESTIGATOR
Jeffrey C. Noroyan, MD
Role: PRINCIPAL_INVESTIGATOR
Fredric S. Brandt, MD
Role: PRINCIPAL_INVESTIGATOR
Robert Dunne, MD
Role: PRINCIPAL_INVESTIGATOR
Marta Rendon, MD
Role: PRINCIPAL_INVESTIGATOR
Kimball W Silverton, DO
Role: PRINCIPAL_INVESTIGATOR
John Tassone, DPM
Role: PRINCIPAL_INVESTIGATOR
Locations
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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Radiant Research, Inc.
Birmingham, Alabama, United States
UAB Department of Dermatology
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Clinical Research Advantage, Inc.
Glendale, Arizona, United States
Radiant Research, Inc.
Tucson, Arizona, United States
Diagnamics, Inc.
Encinatas, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Marta Rendon, MD, Skin Care Research, Inc.
Boca Raton, Florida, United States
Pab Clinical Research
Brandon, Florida, United States
Dermatology Research Institute
Coral Gables, Florida, United States
Ameriderm Research
Jacksonville, Florida, United States
Lake Washington Foot & Ankle Center
Melbourne, Florida, United States
Florida Academic Dermatology Center
Miami, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Leavitt Medical Associates ofFL
Ormond Beach, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
Radiant Research, Inc.
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Derm Research, LLC
Louisville, Kentucky, United States
William P Coleman III, MD
Metairie, Louisiana, United States
Callender center for Clinical Research
Glenn Dale, Maryland, United States
Assoc Foot Clinic & Surgery Specialists
Flint, Michigan, United States
Silverton Skin Institute
Grand Blanc, Michigan, United States
University of Minnesota, Minnesota Clinical Study Center
Fridley, Minnesota, United States
Radiant Research
St Louis, Missouri, United States
Radiant Research, Inc.
Akron, Ohio, United States
Group Health Associates, Tri-Health
Cincinnati, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, United States
University of Pittsburg Medical Center, Department of Dermatology
Pittsburgh, Pennsylvania, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Radiant Research, Inc.
Dallas, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Coastal Podiatry Group
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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HTU-520-US01
Identifier Type: -
Identifier Source: org_study_id
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