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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: IDP-108; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 780
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Guildford Dermatology Specialists
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 1R4
      • Dermadvances Research
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research
  • Ontario
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research, Inc.
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology & Cosmetic Surgery
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research
  • Quebec
    • Westmount, Quebec, Canada, H3Z S26
      • Beatrice Wang, MD
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90036
      • Impact Clinical Trials
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc.
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
    • Santa Rosa, California, United States, 95405
      • Radiant Research
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center Inc
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Ameriderm Research
    • Miami, Florida, United States, 33175
      • FXM Research Corp.
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase Inc.
  • Idaho
    • Nampa, Idaho, United States, 83687
      • Northwest Clinical Trials Nampa
  • Illinois
    • Naperville, Illinois, United States, 60563
      • DuPage Medical Group
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, Dermatology, PLLC
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, P.C.
  • New York
    • New York, New York, United States, 10155
      • Fran E. Cook-Bolden, MD
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of New York, Inc.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Hospitals and School of Medicine
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Medical Research
  • Ohio
    • Warren, Ohio, United States, 44483-6204
      • Brodell Medical, Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Central Sooner Research
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Center, PC
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Palmetto Medical Research
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Dermatology East
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle; Topical application once a day for 48 weeks
Experimental: IDP-108	Drug: IDP-108; Topical application once a day for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who achieve clinical cure	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who achieve clinical efficacy	52 weeks
Percentage of patients who achieve mycologic cure	52 weeks

Collaborators and Investigators

• Sponsor: Dow Pharmaceutical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: DPSI-IDP-108-P3-02