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Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Primary Purpose

Onychomycosis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NAB001
Placebo control
Sponsored by
Promius Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring toenail fungus, onychomycosis, nail infection

Eligibility Criteria

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

Inclusion Criteria:

  • mild to moderate fungal infection of the toenail as assessed by study doctor
  • koh positive & dermatophyte culture positive at Visit 1
  • general good health as assessed by study doctor

Exclusion Criteria:

  • severe fungal toenail infection
  • prior use of antifungal drugs (wash-out allowed, duration varies on class)
  • significant confounding conditions as assessed by study doctor
  • pregnancy/lactation
  • must forego nail salon procedures during study for at least ~60 weeks

Sites / Locations

  • Radiant Research, Inc.
  • Associated Foot & Ankle Specialists, LLC
  • Family Foot Health Center
  • Center for Dermatology Clinical Research, Inc.
  • UCSF Dermatology Research
  • Avail Clinical Research
  • North Florida Dermatology Association
  • Altus Research
  • Lake Washington Foot and Ankle Center
  • Park Avenue Dermatology
  • Radiant Research, Inc.
  • Deaconess Clinic Downtown
  • Michigan Center for Skin Care Research
  • Department of Veteran's Affairs
  • Pinkas Lebovits
  • Skin Search of Rochester, Inc.
  • Care Plus Podiatry, PC
  • Oregon Medical Research Center, PC
  • Radiant Research, Inc.
  • The Skin Wellness Center, PC
  • Research Across America
  • Endeavor Clinical Trials
  • Dermatology Research Center
  • Coastal Podiatry, Inc.
  • Madison Skin and Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active drug

Vehicle alone

Arm Description

Outcomes

Primary Outcome Measures

Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.

Secondary Outcome Measures

Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear).

Full Information

First Posted
September 20, 2010
Last Updated
July 8, 2013
Sponsor
Promius Pharma, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01208129
Brief Title
Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
Official Title
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promius Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
toenail fungus, onychomycosis, nail infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active drug
Arm Type
Experimental
Arm Title
Vehicle alone
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NAB001
Intervention Description
nail lacquer, once daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
nail lacquer, once daily, 52 weeks
Primary Outcome Measure Information:
Title
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
Time Frame
Week 56 after 52 weeks of treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear).
Time Frame
Week 56

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: mild to moderate fungal infection of the toenail as assessed by study doctor koh positive & dermatophyte culture positive at Visit 1 general good health as assessed by study doctor Exclusion Criteria: severe fungal toenail infection prior use of antifungal drugs (wash-out allowed, duration varies on class) significant confounding conditions as assessed by study doctor pregnancy/lactation must forego nail salon procedures during study for at least ~60 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Allenby, MD
Organizational Affiliation
Promius Pharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanne Fraser, PhD
Organizational Affiliation
Promius Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Associated Foot & Ankle Specialists, LLC
City
Phoenix
State/Province
Arkansas
ZIP/Postal Code
85015
Country
United States
Facility Name
Family Foot Health Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
UCSF Dermatology Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
North Florida Dermatology Association
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Lake Washington Foot and Ankle Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Department of Veteran's Affairs
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Pinkas Lebovits
City
New York
State/Province
New York
ZIP/Postal Code
10019
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
Care Plus Podiatry, PC
City
Wading River
State/Province
New York
ZIP/Postal Code
11792
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Radiant Research, Inc.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
The Skin Wellness Center, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Coastal Podiatry, Inc.
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23464
Country
United States
Facility Name
Madison Skin and Research, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

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