search
Back to results

The 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

  • Burke Pharmaceutical Research
  • Impact Clinical Trials
  • Dermatology Research Associates
  • Dermatology Specialists, Inc.
  • Skin Surgery Medical Group, Inc.
  • Center for Clinical Research
  • Radiant Research
  • Colorado Medical Research Center Inc
  • Ameriderm Research
  • FXM Research Corp.
  • MedaPhase Inc.
  • Northwest Clinical Trials Nampa
  • DuPage Medical Group
  • Deaconess Clinic, Inc.
  • South Bend Clinic
  • David Fivenson, MD, Dermatology, PLLC
  • Hamzavi Dermatology
  • Minnesota Clinical Study Center
  • The Dermatology Group, P.C.
  • Fran E. Cook-Bolden, MD
  • Skin Search of Rochester, Inc
  • DermResearchCenter of New York, Inc.
  • University of North Carolina Hospitals and School of Medicine
  • New Hanover Medical Research
  • Brodell Medical, Inc
  • Central Sooner Research
  • Oregon Medical Center, PC
  • Palmetto Medical Research
  • Dermatology East
  • Tennessee Clinical Research Center
  • DermResearch, Inc.
  • Modern Research Associates, PLLC
  • Suzanne Bruce and Associates, PA The Center for Skin Research
  • Endeavor Clinical Trials, PA
  • Premier Clinical Research
  • Madison Skin & Research, Inc.
  • Guildford Dermatology Specialists
  • Dermadvances Research
  • NewLab Clinical Research
  • Lynderm Research, Inc.
  • The Centre for Dermatology & Cosmetic Surgery
  • K. Papp Clinical Research
  • Windsor Clinical Research
  • Beatrice Wang, MD

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
search

1. Study Identification

Unique Protocol Identification Number
NCT01007708
Brief Title
The 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
December 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

Data Monitoring Committee
No

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs