Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
NCT ID: NCT00453271
Last Updated: 2013-05-23
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
443 participants
INTERVENTIONAL
2007-01-31
2008-10-31
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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NB-002 0.25% BID
NB-002
NB-002 0.5% QD
NB-002
NB-002 0.5% BID
NB-002
Vehicle control
Vehicle control
Interventions
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NB-002
Vehicle control
Eligibility Criteria
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Inclusion Criteria
* have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
* positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
* refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
* are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Exclusion Criteria
* are hypersensitive to topical creams, ointments, medications, or surfactants;
* have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
* have taken any investigational drug within 4 weeks prior to the start of the study.
18 Years
75 Years
ALL
Yes
Sponsors
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NanoBio Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Alicia Barba, MD
Role: PRINCIPAL_INVESTIGATOR
International Dermatology Research, Inc.
Alicia Bucko, DO
Role: PRINCIPAL_INVESTIGATOR
Academic Dermatology Associates
Richard Pollak, DPM, MS
Role: PRINCIPAL_INVESTIGATOR
Endeavor Clinical Trials, PA
Michael Jarratt, MD
Role: PRINCIPAL_INVESTIGATOR
Derm Research, PLLC
Terry Jones, MD
Role: PRINCIPAL_INVESTIGATOR
J & S Studies, Inc.
Robert Kaylor, DPM
Role: PRINCIPAL_INVESTIGATOR
Welborne Clinic
Steven Kempers, MD
Role: PRINCIPAL_INVESTIGATOR
Minnesota Clinical Study Center
Robert Matheson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Medical Research Center, PC
Brock McConnehey,, DO
Role: PRINCIPAL_INVESTIGATOR
Northwest Clinical Trial
David Pariser, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Clinical Research, Inc.
Phoebe Rich, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Dermatology and Research Center
Dan Stewart, DO
Role: PRINCIPAL_INVESTIGATOR
Michigan Center for Research Corp
Leonard Swinyer, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Research Center, Inc.
Robert Bissonette, MD
Role: PRINCIPAL_INVESTIGATOR
Innovaderm Research Inc.
Sylvia Garnis-Jones, MD
Role: PRINCIPAL_INVESTIGATOR
EntraLogix Clinical Group Inc.
David Gratton, MD
Role: PRINCIPAL_INVESTIGATOR
International Dermatology Research, Inc.
Lyn Guenther, MD
Role: PRINCIPAL_INVESTIGATOR
The Guenther Dermatology Research Centre
Rod Kunynetz, MD
Role: PRINCIPAL_INVESTIGATOR
Ultranova Skincare
Charles Lynde, MD
Role: PRINCIPAL_INVESTIGATOR
Lynderm Research, Inc.
Richard Langley, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Canada Cutaneous Research Associates, LTD
Kim Papp, MD
Role: PRINCIPAL_INVESTIGATOR
K. Papp Clinical Research
Yves Poulin, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Wayne Gulliver, MD
Role: PRINCIPAL_INVESTIGATOR
Newlab Clinical Research Inc.
R G Sibbald, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Clinic
Locations
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International Dermatology Research
Miami, Florida, United States
Northwest Clinical Trial
Boise, Idaho, United States
Welborne Clinic
Evansville, Indiana, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
DermResearch Inc.
Austin, Texas, United States
J & S Studies, Inc.
Bryan, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Newlab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Research Associates, LTD
Halifax, Nova Scotia, Canada
Ultranova Skincare
Barrie, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research, Inc.
Markham, Ontario, Canada
Dermatology Clinic
Mississauga, Ontario, Canada
EntraLogix Clinical Group, Inc.
Oakville, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm Research, Inc.
Montreal, Quebec, Canada
International Dermatology Research, Inc.
Montreal, Quebec, Canada
Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Québec, Quebec, Canada
Countries
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Other Identifiers
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NB-002-002
Identifier Type: -
Identifier Source: org_study_id
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