The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
1 other identifier
interventional
780
2 countries
44
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
44 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 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 22, 2012
June 1, 2012
2.1 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 (44)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
Skin Surgery Medical Group, Inc.
San Diego, California, 92117, United States
Center for Clinical Research
San Francisco, California, 94115, United States
Radiant Research
Santa Rosa, California, 95405, United States
Colorado Medical Research Center Inc
Denver, Colorado, 80210, United States
Ameriderm Research
Jacksonville, Florida, 32216, United States
FXM Research Corp.
Miami, Florida, 33175, United States
MedaPhase Inc.
Newnan, Georgia, 30263, United States
Northwest Clinical Trials Nampa
Nampa, Idaho, 83687, United States
DuPage Medical Group
Naperville, Illinois, 60563, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
The Dermatology Group, P.C.
Verona, New Jersey, 07044, United States
Fran E. Cook-Bolden, MD
New York, New York, 10155, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790, United States
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, 27599, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
Brodell Medical, Inc
Warren, Ohio, 44483-6204, United States
Central Sooner Research
Norman, Oklahoma, 73069, United States
Oregon Medical Center, PC
Portland, Oregon, 97223, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464, United States
Dermatology East
Germantown, Tennessee, 38138, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Suzanne Bruce and Associates, PA The Center for Skin Research
Houston, Texas, 77056, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719, United States
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7, Canada
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4, Canada
NewLab Clinical Research
St. John's, Newfoundland and Labrador, A1C 2H5, Canada
Lynderm Research, Inc.
Markham, Ontario, L3P 1A8, Canada
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Windsor Clinical Research
Windsor, Ontario, N8W 5L7, Canada
Beatrice Wang, MD
Westmount, Quebec, H3Z S26, Canada
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 4, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 22, 2012
Record last verified: 2012-06