Clinical trial NCT01008033: Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2009-11-05
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* 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:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* 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

Primary outcomes:
measure: Percentage of patients who achieve clinical cure
timeFrame: 52 weeks
Secondary outcomes:
measure: Percentage of patients who achieve clinical efficacy
timeFrame: 52 weeks
measure: Percentage of patients who achieve mycologic cure
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Altamonte Springs
country: United States
facility: Foot and Ankle Associates of Florida, Inc
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Augusta
country: United States
facility: Augusta Centre for Dermatology and Skin Renewal, LLC
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology
state: New Mexico
city: New Hyde Park
country: United States
facility: Impact Clinical Trials
state: New York
city: Cinncinati
country: United States
facility: Radiant Research
state: Ohio
city: South Euclid
country: United States
facility: Haber Dermatology & Cosmetic Surgery
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller, MD, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Resarch Center
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc. - Clinical Research Center
state: Wisconsin
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: New London
country: Canada
facility: Mediprobe Research
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche Dermatologique du Québec Métropolitain
state: Quebec
city: Dazaifu
country: Japan
facility: Kaken Investigational Site
state: Fukuoka
city: Itoshima
country: Japan
facility: Kaken Investigational Site
state: Fukuoka
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Atsubetsu-ku #1
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Atsubetsu-ku #2
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Atsubetsu-ku #3
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Chuo-ku
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Kita-ku
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Kiyota-ku
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Nishi-ku
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Shiroishi-ku
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Teine-ku #1
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site - Teine-ku #2
state: Hokkaido
city: Kawasaki
country: Japan
facility: Kaken Investigational Site
state: Kanagawa
city: Ginowan
country: Japan
facility: Kaken Investigational Site
state: Okinawa
city: Naha
country: Japan
facility: Kaken Investigational Site
state: Okinawa
city: Nakagami
country: Japan
facility: Kaken Investigational Site
state: Okinawa
city: Urasoe
country: Japan
facility: Kaken Investigational Site
state: Okinawa
city: Kawaguchi
country: Japan
facility: Kaken Investigational Site
state: Saitama
city: Nakano-ku
country: Japan
facility: Kaken Investigational Site - Nakano-ku #1
state: Tokyo
city: Nakano-ku
country: Japan
facility: Kaken Investigational Site - Nakano-ku #2
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Kaken Investigational Site - Setagaya-ku #1
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Kaken Investigational Site - Setagaya-ku #2
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kaken Investigational Site - Shinagawa-ku #1
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kaken Investigational Site - Shinagawa-ku #2
state: Tokyo
city: Fukuoka
country: Japan
facility: Kaken Investigational Site - Chuo-ku #1
city: Fukuoka
country: Japan
facility: Kaken Investigational Site - Chuo-ku #2
city: Fukuoka
country: Japan
facility: Kaken Investigational Site - Higashi-ku
city: Fukuoka
country: Japan
facility: Kaken Investigational Site - Minami-ku #1
city: Fukuoka
country: Japan
facility: Kaken Investigational Site - Minami-ku #2
city: Nagasaki
country: Japan
facility: Kaken Investigational Site
city: Okinawa
country: Japan
facility: Kaken Investigational Site - Okinawa #1
city: Okinawa
country: Japan
facility: Kaken Investigational Site - Okinawa #2
Study officials:
References:
citation: 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.