The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
NCT ID: NCT01007708
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
780 participants
INTERVENTIONAL
2009-11-30
2011-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
NCT01008033
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
NCT00777868
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
NCT01208168
Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
NCT03094468
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
NCT05089409
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IDP-108
IDP-108
Topical application once a day for 48 weeks
Vehicle
Vehicle
Topical application once a day for 48 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IDP-108
Topical application once a day for 48 weeks
Vehicle
Topical application once a day for 48 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dow Pharmaceutical Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Impact Clinical Trials
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists, Inc.
Oceanside, California, 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
Colorado Medical Research Center Inc
Denver, Colorado, United States
Ameriderm Research
Jacksonville, Florida, United States
FXM Research Corp.
Miami, Florida, United States
MedaPhase Inc.
Newnan, Georgia, United States
Northwest Clinical Trials Nampa
Nampa, Idaho, United States
DuPage Medical Group
Naperville, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
The Dermatology Group, P.C.
Verona, New Jersey, United States
Fran E. Cook-Bolden, MD
New York, New York, United States
Skin Search of Rochester, Inc
Rochester, New York, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, United States
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Brodell Medical, Inc
Warren, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Oregon Medical Center, PC
Portland, Oregon, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Dermatology East
Germantown, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
Suzanne Bruce and Associates, PA The Center for Skin Research
Houston, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, United States
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Dermadvances Research
Winnipeg, Manitoba, Canada
NewLab Clinical Research
St. John's, Newfoundland and Labrador, Canada
Lynderm Research, Inc.
Markham, Ontario, Canada
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Windsor Clinical Research
Windsor, Ontario, Canada
Beatrice Wang, MD
Westmount, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DPSI-IDP-108-P3-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.