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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IDP-108
Vehicle
Sponsored by
Dow Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama, Birmingham
  • HOPE Research Institute
  • Therapeutics Clinical Research
  • University Clinical Trials, Inc
  • University of California, San Francisco
  • Longmont Medical Research Network
  • The Savin Center, PC
  • Foot and Ankle Associates of Florida, Inc
  • International Dermatology Research, Inc.
  • Ameriderm Research
  • Augusta Centre for Dermatology and Skin Renewal, LLC
  • Gwinnett Clinical Research Center, Inc.
  • Northwest Clinical Trials
  • Hudson Dermatology
  • Dermatology Specialists
  • Michigan Center for Research Corp.
  • Academic Dermatology
  • Impact Clinical Trials
  • Radiant Research
  • Haber Dermatology & Cosmetic Surgery
  • Oregon Dermatology and Research Center
  • Penn State Milton S. Hershey Medical Center
  • Temple University School of Podiatric Medicine
  • Palmetto Clinical Trial Services, LLC
  • Rivergate Dermatology
  • Austin Dermatology Associates
  • J & S Studies, Inc.
  • Baylor Research Institute
  • Stephen Miller, MD, PA
  • Dermatology Resarch Center
  • The Education and Research Foundation, Inc.
  • Virginia Clinical Research, Inc
  • Aurora Advanced Healthcare, Inc. - Clinical Research Center
  • Kirk Barber Research
  • Stratica Medical
  • Ultranova Skincare
  • Mediprobe Research
  • North Bay Dermatology Centre
  • XLR8 Medical Research
  • Centre de Recherche Dermatologique du Québec Métropolitain
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site - Atsubetsu-ku #1
  • Kaken Investigational Site - Atsubetsu-ku #2
  • Kaken Investigational Site - Atsubetsu-ku #3
  • Kaken Investigational Site - Chuo-ku
  • Kaken Investigational Site - Kita-ku
  • Kaken Investigational Site - Kiyota-ku
  • Kaken Investigational Site - Nishi-ku
  • Kaken Investigational Site - Shiroishi-ku
  • Kaken Investigational Site - Teine-ku #1
  • Kaken Investigational Site - Teine-ku #2
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site
  • Kaken Investigational Site - Nakano-ku #1
  • Kaken Investigational Site - Nakano-ku #2
  • Kaken Investigational Site - Setagaya-ku #1
  • Kaken Investigational Site - Setagaya-ku #2
  • Kaken Investigational Site - Shinagawa-ku #1
  • Kaken Investigational Site - Shinagawa-ku #2
  • Kaken Investigational Site - Chuo-ku #1
  • Kaken Investigational Site - Chuo-ku #2
  • Kaken Investigational Site - Higashi-ku
  • Kaken Investigational Site - Minami-ku #1
  • Kaken Investigational Site - Minami-ku #2
  • Kaken Investigational Site
  • Kaken Investigational Site - Okinawa #1
  • Kaken Investigational Site - Okinawa #2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IDP-108

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients who achieve clinical cure

Secondary Outcome Measures

Percentage of patients who achieve clinical efficacy
Percentage of patients who achieve mycologic cure

Full Information

First Posted
November 3, 2009
Last Updated
June 20, 2012
Sponsor
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01008033
Brief Title
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow Pharmaceutical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
870 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDP-108
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IDP-108
Intervention Description
Topical application once a day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical application once a day for 48 weeks
Primary Outcome Measure Information:
Title
Percentage of patients who achieve clinical cure
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients who achieve clinical efficacy
Time Frame
52 weeks
Title
Percentage of patients who achieve mycologic cure
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University Clinical Trials, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Foot and Ankle Associates of Florida, Inc
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Augusta Centre for Dermatology and Skin Renewal, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Michigan Center for Research Corp.
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Academic Dermatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Impact Clinical Trials
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Radiant Research
City
Cinncinati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Haber Dermatology & Cosmetic Surgery
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University School of Podiatric Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Austin Dermatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Stephen Miller, MD, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Resarch Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education and Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Aurora Advanced Healthcare, Inc. - Clinical Research Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Mediprobe Research
City
New London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
XLR8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Québec Métropolitain
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Kaken Investigational Site
City
Dazaifu
State/Province
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site
City
Itoshima
State/Province
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site - Atsubetsu-ku #1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Atsubetsu-ku #2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Atsubetsu-ku #3
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Chuo-ku
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Kita-ku
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Kiyota-ku
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Nishi-ku
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Shiroishi-ku
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Teine-ku #1
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site - Teine-ku #2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kaken Investigational Site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Ginowan
State/Province
Okinawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Naha
State/Province
Okinawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Nakagami
State/Province
Okinawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Urasoe
State/Province
Okinawa
Country
Japan
Facility Name
Kaken Investigational Site
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Kaken Investigational Site - Nakano-ku #1
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Nakano-ku #2
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Setagaya-ku #1
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Setagaya-ku #2
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Shinagawa-ku #1
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Shinagawa-ku #2
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kaken Investigational Site - Chuo-ku #1
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site - Chuo-ku #2
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site - Higashi-ku
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site - Minami-ku #1
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site - Minami-ku #2
City
Fukuoka
Country
Japan
Facility Name
Kaken Investigational Site
City
Nagasaki
Country
Japan
Facility Name
Kaken Investigational Site - Okinawa #1
City
Okinawa
Country
Japan
Facility Name
Kaken Investigational Site - Okinawa #2
City
Okinawa
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25007364
Citation
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.
Results Reference
derived

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

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