Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Onychomycosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008033
• Other study ID #: DPSI-IDP-108-P3-01
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2009
• Last updated: June 20, 2012
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Dow Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• IDP-108
Topical application once a day for 48 weeks
• Vehicle
Topical application once a day for 48 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dow Pharmaceutical Sciences

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who achieve clinical cure		52 weeks	No
Secondary	Percentage of patients who achieve clinical efficacy		52 weeks	No
Secondary	Percentage of patients who achieve mycologic cure		52 weeks	No