Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail
This study has been completed.
Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Onychomycosis |
Drug: HTU-520 patch & 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 & Placebo patch
Subjects will receive either HTU-520 patch or placebo patch in a 1:1 ratio for 48 weeks applied to all toenails.
|
Drug: HTU-520 patch & Placebo patch
Terbinafine hydrochloride patch
Other Name: HTU-520
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400594
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Total Skin and Beauty Dermatology Center | |
| Birmingham, Alabama, United States, 35205 | |
| Radiant Research, Inc. | |
| Birmingham, Alabama, United States, 35209 | |
| UAB Department of Dermatology | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Clinical Research Advantage, Inc. | |
| Glendale, Arizona, United States, 85306 | |
| Radiant Research, Inc. | |
| Tucson, Arizona, United States, 85710 | |
| United States, California | |
| Diagnamics, Inc. | |
| Encinatas, California, United States, 92024 | |
| United States, Colorado | |
| Radiant Research, Inc. | |
| Denver, Colorado, United States, 80239 | |
| United States, Florida | |
| Center for Clinical and Cosmetic Research | |
| Aventura, Florida, United States, 33180 | |
| Marta Rendon, MD, Skin Care Research, Inc. | |
| Boca Raton, Florida, United States, 33486 | |
| Pab Clinical Research | |
| Brandon, Florida, United States, 33511 | |
| Dermatology Research Institute | |
| Coral Gables, Florida, United States, 33146 | |
| Ameriderm Research | |
| Jacksonville, Florida, United States, 32216 | |
| Lake Washington Foot & Ankle Center | |
| Melbourne, Florida, United States, 32935 | |
| Florida Academic Dermatology Center | |
| Miami, Florida, United States, 33136 | |
| Leavitt Medical Associates ofFL | |
| Ormond Beach, Florida, United States, 32174 | |
| Ameriderm Research | |
| Ormond Beach, Florida, United States, 32174 | |
| Radiant Research, Inc. | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Georgia | |
| Radiant Research, Inc. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Radiant Research, Inc. | |
| Chicago, Illinois, United States, 60654 | |
| United States, Indiana | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Kentucky | |
| Derm Research, LLC | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Louisiana | |
| William P Coleman III, MD | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| Callender center for Clinical Research | |
| Glenn Dale, Maryland, United States, 20769 | |
| United States, Michigan | |
| Assoc Foot Clinic & Surgery Specialists | |
| Flint, Michigan, United States, 48503 | |
| Silverton Skin Institute | |
| Grand Blanc, Michigan, United States, 48439 | |
| United States, Minnesota | |
| University of Minnesota, Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Missouri | |
| Radiant Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Ohio | |
| Radiant Research, Inc. | |
| Akron, Ohio, United States, 44311 | |
| Group Health Associates, Tri-Health | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Oklahoma | |
| Central Sooner Research | |
| Norman, Oklahoma, United States, 73071 | |
| United States, Pennsylvania | |
| Society Hill Dermatology | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| University of Pittsburg Medical Center, Department of Dermatology | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Radiant Research, Inc. | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Texas | |
| Radiant Research, Inc. | |
| Dallas, Texas, United States, 75231 | |
| Radiant Research, Inc. | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Coastal Podiatry Group | |
| Virginia Beach, Virginia, United States, 23464 | |
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Investigators
| 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. |
| ClinicalTrials.gov Identifier: | NCT01400594 History of Changes |
| Other Study ID Numbers: | HTU-520-US01 |
| Study First Received: | July 20, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
|
Onychomycosis |
Additional relevant MeSH terms:
|
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious |
Infection Mycoses Nail Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013