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

Primary Purpose

Onychomycosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NAB001
Vehicle alone
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
  • good general health as assessed by the 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

  • T. Joseph Raoof, MD, Inc.
  • Skin Surgery Medical Group, Inc.
  • Longmont Medical Research Network
  • Jacksonville Center for Clinical Research
  • Internaional Dermatology Research, Inc.
  • MedaPhase, Inc.
  • Clinical Research Atlanta
  • Northwest Clinical Trials
  • Minnesota Clinical Study Center
  • Gerard Furst, DPM, PLLC
  • Dermatology Consulting Services
  • Wake Research Associates
  • Mazur Foot and Ankle
  • Radiant Research
  • Oregon Dermatology & Research Network
  • Temple University - School of Podiatric Medicine
  • Carolina Dermatology of Greenville, PA
  • Coastal Carolina Research Center
  • Tennessee Clinical Research Center
  • Ashton Podiatry Associates, PA
  • Progressive Clinical Research
  • Instituto Dermatologica
  • Instituto Dermatologico

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
NCT01208168
Brief Title
Safety & 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 Wks
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
468 (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)
Vehicle alone
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 good general health as assessed by the 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:
City
Phoenix
State/Province
Arkansas
ZIP/Postal Code
85032
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
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
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Internaional Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Gerard Furst, DPM, PLLC
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Mazur Foot and Ankle
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Oregon Dermatology & Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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
Carolina Dermatology of Greenville, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Ashton Podiatry Associates, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Instituto Dermatologica
City
Santo Domingo
Country
Dominican Republic
Facility Name
Instituto Dermatologico
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Learn more about this trial

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

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