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): 870
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2S 3B3
      • Kirk Barber Research
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Ultranova Skincare
    • New London, Ontario, Canada, N5X 2P1
      • Mediprobe Research
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research
  • Quebec
    • Québec, Quebec, Canada, G1V 4X7
      • Centre de Recherche Dermatologique Du Quebec Metropolitain
• Japan
  • 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
  • Nagasaki, Japan
    • Kaken Investigational Site
  • Okinawa, Japan
    • Kaken Investigational Site - Okinawa #1
  • Okinawa, Japan
    • Kaken Investigational Site - Okinawa #2
  • Fukuoka
    • Dazaifu, Fukuoka, Japan
      • Kaken Investigational Site
    • Itoshima, Fukuoka, Japan
      • Kaken Investigational Site
  • Hokkaido
    • Sapporo, Hokkaido, 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
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Kaken Investigational Site
  • Okinawa
    • Ginowan, Okinawa, Japan
      • Kaken Investigational Site
    • Naha, Okinawa, Japan
      • Kaken Investigational Site
    • Nakagami, Okinawa, Japan
      • Kaken Investigational Site
    • Urasoe, Okinawa, Japan
      • Kaken Investigational Site
  • Saitama
    • Kawaguchi, Saitama, Japan
      • Kaken Investigational Site
  • Tokyo
    • Nakano-ku, Tokyo, Japan
      • Kaken Investigational Site - Nakano-ku #1
    • Nakano-ku, Tokyo, Japan
      • Kaken Investigational Site - Nakano-ku #2
    • Setagaya-ku, Tokyo, Japan
      • Kaken Investigational Site - Setagaya-ku #1
    • Setagaya-ku, Tokyo, Japan
      • Kaken Investigational Site - Setagaya-ku #2
    • Shinagawa-ku, Tokyo, Japan
      • Kaken Investigational Site - Shinagawa-ku #1
    • Shinagawa-ku, Tokyo, Japan
      • Kaken Investigational Site - Shinagawa-ku #2
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama, Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Diego, California, United States, 92123
      • University Clinical Trials, Inc
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
  • Colorado
    • Longmont, Colorado, United States, 80501
      • Longmont Medical Research Network
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Foot and Ankle Associates of Florida, Inc
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Augusta Centre for Dermatology and Skin Renewal, LLC
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc.
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Research Corp.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology
  • New York
    • New Hyde Park, New York, United States, 11040
      • Impact Clinical Trials
  • Ohio
    • Cinncinati, Ohio, United States, 45249
      • Radiant Research
    • South Euclid, Ohio, United States, 44118
      • Haber Dermatology & Cosmetic Surgery
  • Oregon
    • Portland, Oregon, United States, 97219
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Temple University School of Podiatric Medicine
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc.
    • Dallas, Texas, United States, 75246
      • Baylor Research Institute
    • San Antonio, Texas, United States, 78229
      • Stephen Miller, MD, PA
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Resarch Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation, Inc.
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Advanced Healthcare, Inc. - Clinical Research Center

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): November 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 5, 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-P3-01