Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
NCT ID: NCT01008033
Last Updated: 2012-06-22
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
PHASE3
870 participants
INTERVENTIONAL
2009-11-30
2011-12-31
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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IDP-108
IDP-108
Topical application once a day for 48 weeks
Vehicle
Vehicle
Topical application once a day for 48 weeks
Interventions
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IDP-108
Topical application once a day for 48 weeks
Vehicle
Topical application once a day for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail
Exclusion Criteria
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
18 Years
70 Years
ALL
No
Sponsors
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Dow Pharmaceutical Sciences
INDUSTRY
Responsible Party
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Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
Therapeutics Clinical Research
San Diego, California, United States
University Clinical Trials, Inc
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Longmont Medical Research Network
Longmont, Colorado, United States
The Savin Center, PC
New Haven, Connecticut, United States
Foot and Ankle Associates of Florida, Inc
Altamonte Springs, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Augusta Centre for Dermatology and Skin Renewal, LLC
Augusta, Georgia, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Hudson Dermatology
Evansville, Indiana, United States
Dermatology Specialists
Louisville, Kentucky, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, United States
Academic Dermatology
Albuquerque, New Mexico, United States
Impact Clinical Trials
New Hyde Park, New York, United States
Radiant Research
Cinncinati, Ohio, United States
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Rivergate Dermatology
Goodlettsville, Tennessee, United States
Austin Dermatology Associates
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Stephen Miller, MD, PA
San Antonio, Texas, United States
Dermatology Resarch Center
Salt Lake City, Utah, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Aurora Advanced Healthcare, Inc. - Clinical Research Center
Milwaukee, Wisconsin, United States
Kirk Barber Research
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Ultranova Skincare
Barrie, Ontario, Canada
Mediprobe Research
New London, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Centre de Recherche Dermatologique du Québec Métropolitain
Québec, Quebec, Canada
Kaken Investigational Site
Dazaifu, Fukuoka, Japan
Kaken Investigational Site - Chuo-ku #1
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Chuo-ku #2
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Higashi-ku
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Minami-ku #1
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Minami-ku #2
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Itoshima, Fukuoka, Japan
Kaken Investigational Site - Atsubetsu-ku #1
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Atsubetsu-ku #2
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Atsubetsu-ku #3
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Chuo-ku
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Kita-ku
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Kiyota-ku
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Nishi-ku
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Shiroishi-ku
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Teine-ku #1
Sapporo, Hokkaido, Japan
Kaken Investigational Site - Teine-ku #2
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Kawasaki, Kanagawa, Japan
Kaken Investigational Site
Nagasaki, Nagasaki, Japan
Kaken Investigational Site
Ginowan, Okinawa, Japan
Kaken Investigational Site
Naha, Okinawa, Japan
Kaken Investigational Site
Nakagami, Okinawa, Japan
Kaken Investigational Site - Okinawa #1
Okinawa, Okinawa, Japan
Kaken Investigational Site - Okinawa #2
Okinawa, Okinawa, Japan
Kaken Investigational Site
Urasoe, Okinawa, Japan
Kaken Investigational Site
Kawaguchi, Saitama, Japan
Kaken Investigational Site - Nakano-ku #1
Nakano-ku, Tokyo, Japan
Kaken Investigational Site - Nakano-ku #2
Nakano-ku, Tokyo, Japan
Kaken Investigational Site - Setagaya-ku #1
Setagaya-ku, Tokyo, Japan
Kaken Investigational Site - Setagaya-ku #2
Setagaya-ku, Tokyo, Japan
Kaken Investigational Site - Shinagawa-ku #1
Shinagawa-ku, Tokyo, Japan
Kaken Investigational Site - Shinagawa-ku #2
Shinagawa-ku, Tokyo, Japan
Countries
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References
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Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20.
Other Identifiers
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DPSI-IDP-108-P3-01
Identifier Type: -
Identifier Source: org_study_id
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