Clinical trial NCT01007708: The 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: 2009-11-04
Enrollment: 780
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: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center Inc
state: Colorado
city: Jacksonville
country: United States
facility: Ameriderm Research
state: Florida
city: Miami
country: United States
facility: FXM Research Corp.
state: Florida
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Nampa
country: United States
facility: Northwest Clinical Trials Nampa
state: Idaho
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Ann Arbor
country: United States
facility: David Fivenson, MD, Dermatology, PLLC
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: New York
country: United States
facility: Fran E. Cook-Bolden, MD
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals and School of Medicine
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Warren
country: United States
facility: Brodell Medical, Inc
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Center, PC
state: Oregon
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Germantown
country: United States
facility: Dermatology East
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Madison
country: United States
facility: Madison Skin & Research, Inc.
state: Wisconsin
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: St. John's
country: Canada
facility: NewLab Clinical Research
state: Newfoundland and Labrador
city: Markham
country: Canada
facility: Lynderm Research, Inc.
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology & Cosmetic Surgery
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Westmount
country: Canada
facility: Beatrice Wang, MD
state: Quebec
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.