Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
1 other identifier
interventional
870
3 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2009
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 22, 2012
June 1, 2012
2 years
November 3, 2009
June 20, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients who achieve clinical cure
52 weeks
Secondary Outcomes (2)
Percentage of patients who achieve clinical efficacy
52 weeks
Percentage of patients who achieve mycologic cure
52 weeks
Study Arms (2)
IDP-108
EXPERIMENTALVehicle
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
University of Alabama, Birmingham
Birmingham, Alabama, 35233, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
University Clinical Trials, Inc
San Diego, California, 92123, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
Foot and Ankle Associates of Florida, Inc
Altamonte Springs, Florida, 32701, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Ameriderm Research
Ormond Beach, Florida, 32174, United States
Augusta Centre for Dermatology and Skin Renewal, LLC
Augusta, Georgia, 30909, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Hudson Dermatology
Evansville, Indiana, 47714, United States
Dermatology Specialists
Louisville, Kentucky, 40202, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, 48038, United States
Academic Dermatology
Albuquerque, New Mexico, 87106, United States
Impact Clinical Trials
New Hyde Park, New York, 11040, United States
Radiant Research
Cinncinati, Ohio, 45249, United States
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, 44118, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97219, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29607, United States
Rivergate Dermatology
Goodlettsville, Tennessee, 37072, United States
Austin Dermatology Associates
Austin, Texas, 78705, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
Stephen Miller, MD, PA
San Antonio, Texas, 78229, United States
Dermatology Resarch Center
Salt Lake City, Utah, 84124, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507, United States
Aurora Advanced Healthcare, Inc. - Clinical Research Center
Milwaukee, Wisconsin, 53209, United States
Kirk Barber Research
Calgary, Alberta, T2S 3B3, Canada
Stratica Medical
Edmonton, Alberta, T5K 1X3, Canada
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
Mediprobe Research
New London, Ontario, N5X 2P1, Canada
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
XLR8 Medical Research
Windsor, Ontario, N8W 1E6, Canada
Centre de Recherche Dermatologique du Québec Métropolitain
Québec, Quebec, G1V 4X7, Canada
Kaken Investigational Site
Dazaifu, Fukuoka, Japan
Kaken Investigational Site - Chuo-ku #1
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Chuo-ku #2
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Higashi-ku
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Minami-ku #1
Fukuoka, Fukuoka, Japan
Kaken Investigational Site - Minami-ku #2
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Itoshima, Fukuoka, 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
Kawasaki, Kanagawa, Japan
Kaken Investigational Site
Nagasaki, Nagasaki, Japan
Kaken Investigational Site
Ginowan, Okinawa, Japan
Kaken Investigational Site
Naha, Okinawa, Japan
Kaken Investigational Site
Nakagami, Okinawa, Japan
Kaken Investigational Site - Okinawa #1
Okinawa, Okinawa, Japan
Kaken Investigational Site - Okinawa #2
Okinawa, Okinawa, Japan
Kaken Investigational Site
Urasoe, Okinawa, Japan
Kaken Investigational Site
Kawaguchi, Saitama, Japan
Kaken Investigational Site - Nakano-ku #1
Nakano-ku, Tokyo, Japan
Kaken Investigational Site - Nakano-ku #2
Nakano-ku, Tokyo, 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
Related Publications (1)
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.
PMID: 25007364DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 5, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
June 22, 2012
Record last verified: 2012-06