CompletedNCT01008033Updated Jun 22, 2012

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

A Phase 3 interventional study of IDP-108 and Vehicle in Onychomycosis, sponsored by Dow Pharmaceutical Sciences. Completed at 72 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-06-22.

Sponsored by Dow Pharmaceutical Sciences (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 870
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Onychomycosis

Browse trials for

Onychomycosis 152

In context

Onychomycosis

152 studies on the registry are indexed under Onychomycosis; 14 are open to participants now.

This study's enrollment of 870 is above the median of 60 across 138 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

Dow Pharmaceutical Sciences is the lead sponsor of 9 studies on the registry; none are open to participants now.

First submitted before Dow Pharmaceutical Sciences became part of Bausch Health Companies Inc..

Browse Dow Pharmaceutical Sciences studies →All Bausch Health Companies Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 870 participants (actual)

Study arms

Experimental
IDP-108
Drug: IDP-108
Placebo comparator
Vehicle
Drug: Vehicle

Interventions

DrugIDP-108
Topical application once a day for 48 weeks
DrugVehicle
Topical application once a day for 48 weeks

What researchers measure

Primary outcomes

Percentage of patients who achieve clinical cure
Time frame: 52 weeks

Secondary outcomes

Percentage of patients who achieve clinical efficacy
Time frame: 52 weeks
Percentage of patients who achieve mycologic cure
Time frame: 52 weeks

Study locations

72 sites

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

References and documents

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. PubMed 25007364 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01008033
Lead sponsor: Dow Pharmaceutical Sciences
Responsible party: Sponsor
First posted: Nov 5, 2009
Start date: Nov 2009
Primary completion: Nov 2011
Completion: Dec 2011
Last update: Jun 22, 2012

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Efinaconazole

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