The 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: NCT01007708
• Other study ID #: DPSI-IDP-108-P3-02
• 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 Canada
• 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: 780
• Est. completion date: December 2011
• Est. primary completion date: December 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	Lynderm Research, Inc.	Markham	Ontario
Canada	The Centre for Dermatology & Cosmetic Surgery	Richmond Hill	Ontario
Canada	NewLab Clinical Research	St. John's	Newfoundland and Labrador
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Canada	Beatrice Wang, MD	Westmount	Quebec
Canada	Windsor Clinical Research	Windsor	Ontario
Canada	Dermadvances Research	Winnipeg	Manitoba
United States	David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan
United States	DermResearch, Inc.	Austin	Texas
United States	University of North Carolina Hospitals and School of Medicine	Chapel Hill	North Carolina
United States	Modern Research Associates, PLLC	Dallas	Texas
United States	Colorado Medical Research Center Inc	Denver	Colorado
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology East	Germantown	Tennessee
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Suzanne Bruce and Associates, PA The Center for Skin Research	Houston	Texas
United States	Ameriderm Research	Jacksonville	Florida
United States	Dermatology Research Associates	Los Angeles	California
United States	Impact Clinical Trials	Los Angeles	California
United States	Madison Skin & Research, Inc.	Madison	Wisconsin
United States	FXM Research Corp.	Miami	Florida
United States	Palmetto Medical Research	Mt. Pleasant	South Carolina
United States	Northwest Clinical Trials Nampa	Nampa	Idaho
United States	DuPage Medical Group	Naperville	Illinois
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Fran E. Cook-Bolden, MD	New York	New York
United States	MedaPhase Inc.	Newnan	Georgia
United States	Central Sooner Research	Norman	Oklahoma
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Oregon Medical Center, PC	Portland	Oregon
United States	Skin Search of Rochester, Inc	Rochester	New York
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	Center for Clinical Research	San Francisco	California
United States	Radiant Research	Santa Rosa	California
United States	South Bend Clinic	South Bend	Indiana
United States	Premier Clinical Research	Spokane	Washington
United States	DermResearchCenter of New York, Inc.	Stony Brook	New York
United States	The Dermatology Group, P.C.	Verona	New Jersey
United States	Brodell Medical, Inc	Warren	Ohio
United States	New Hanover Medical Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dow Pharmaceutical Sciences

Countries where clinical trial is conducted

United States,  Canada, 

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