Back to resultsTreatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NB-002
Vehicle control
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring chronic persistent infection of the nail bed or plate
Eligibility Criteria
Inclusion Criteria:
- are healthy males or females between the ages of 18 and 75 years of age;
- have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Exclusion Criteria:
- females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- are hypersensitive to topical creams, ointments, medications, or surfactants;
- have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- have taken any investigational drug within 4 weeks prior to the start of the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- International Dermatology Research
- Northwest Clinical Trial
- Welborne Clinic
- Michigan Center for Research Corp.
- Minnesota Clinical Study Center
- Academic Dermatology Associates
- Oregon Dermatology and Research Center
- Oregon Medical Research Center, PC
- DermResearch Inc.
- J & S Studies, Inc.
- Endeavor Clinical Trials, PA
- Dermatology Research Center, Inc.
- Virginia Clinical Research, Inc.
- Newlab Clinical Research, Inc.
- Eastern Canada Cutaneous Research Associates, LTD
- Ultranova Skincare
- The Guenther Dermatology Research Centre
- Lynderm Research, Inc.
- Dermatology Clinic
- EntraLogix Clinical Group, Inc.
- K. Papp Clinical Research
- Innovaderm Research, Inc.
- International Dermatology Research, Inc.
- Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
NB-002 0.25% BID
NB-002 0.5% QD
NB-002 0.5% BID
Vehicle control
Arm Description
Outcomes
Primary Outcome Measures
Planimetry assessment of the target great toenail
Rate of complete cure
Rate of therapeutic success
Secondary Outcome Measures
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453271
Brief Title
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Official Title
A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanoBio Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Detailed Description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
chronic persistent infection of the nail bed or plate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
443 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NB-002 0.25% BID
Arm Type
Experimental
Arm Title
NB-002 0.5% QD
Arm Type
Experimental
Arm Title
NB-002 0.5% BID
Arm Type
Experimental
Arm Title
Vehicle control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
NB-002
Intervention Type
Drug
Intervention Name(s)
Vehicle control
Primary Outcome Measure Information:
Title
Planimetry assessment of the target great toenail
Time Frame
Week 24
Title
Rate of complete cure
Time Frame
Week 46
Title
Rate of therapeutic success
Time Frame
Week 46
Secondary Outcome Measure Information:
Title
Investigator's visual assessment of length of new unaffected nail
Title
The presence/absence of DSO on all toenails
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
are healthy males or females between the ages of 18 and 75 years of age;
have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
Exclusion Criteria:
females who are pregnant, plan to become pregnant during the study, or are nursing a child;
are hypersensitive to topical creams, ointments, medications, or surfactants;
have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
have taken any investigational drug within 4 weeks prior to the start of the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Barba, MD
Organizational Affiliation
International Dermatology Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alicia Bucko, DO
Organizational Affiliation
Academic Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Pollak, DPM, MS
Organizational Affiliation
Endeavor Clinical Trials, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Jarratt, MD
Organizational Affiliation
Derm Research, PLLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry Jones, MD
Organizational Affiliation
J & S Studies, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Kaylor, DPM
Organizational Affiliation
Welborne Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Organizational Affiliation
Minnesota Clinical Study Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Matheson, MD
Organizational Affiliation
Oregon Medical Research Center, PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brock McConnehey,, DO
Organizational Affiliation
Northwest Clinical Trial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Pariser, MD
Organizational Affiliation
Virginia Clinical Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phoebe Rich, MD
Organizational Affiliation
Oregon Dermatology and Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Stewart, DO
Organizational Affiliation
Michigan Center for Research Corp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonard Swinyer, MD
Organizational Affiliation
Dermatology Research Center, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Bissonette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvia Garnis-Jones, MD
Organizational Affiliation
EntraLogix Clinical Group Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Gratton, MD
Organizational Affiliation
International Dermatology Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyn Guenther, MD
Organizational Affiliation
The Guenther Dermatology Research Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rod Kunynetz, MD
Organizational Affiliation
Ultranova Skincare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Lynde, MD
Organizational Affiliation
Lynderm Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Langley, MD
Organizational Affiliation
Eastern Canada Cutaneous Research Associates, LTD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Papp, MD
Organizational Affiliation
K. Papp Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves Poulin, MD
Organizational Affiliation
Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wayne Gulliver, MD
Organizational Affiliation
Newlab Clinical Research Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R G Sibbald, MD
Organizational Affiliation
Dermatology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Northwest Clinical Trial
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Welborne Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
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
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
DermResearch Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Newlab Clinical Research, Inc.
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 4S8
Country
Canada
Facility Name
Eastern Canada Cutaneous Research Associates, LTD
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1A4
Country
Canada
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
The Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research, Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
Dermatology Clinic
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 1A6
Country
Canada
Facility Name
EntraLogix Clinical Group, Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6K1E1
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Innovaderm Research, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
International Dermatology Research, Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1U4
Country
Canada
Facility Name
Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
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