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

July 8, 2013 updated by: Promius Pharma, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Radiant Research, Inc.
    • Arkansas
      • Phoenix, Arkansas, United States, 85015
        • Associated Foot & Ankle Specialists, LLC
      • Rogers, Arkansas, United States, 72758
        • Family Foot Health Center
    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • San Francisco, California, United States, 94115
        • UCSF Dermatology Research
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Association
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Melbourne, Florida, United States, 32935
        • Lake Washington Foot and Ankle Center
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research, Inc.
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic Downtown
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Michigan Center for Skin Care Research
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Department of Veteran's Affairs
    • New York
      • New York, New York, United States, 10019
        • Pinkas Lebovits
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester, Inc.
      • Wading River, New York, United States, 11792
        • Care Plus Podiatry, PC
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center, Pc
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Radiant Research, Inc.
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center, PC
    • Texas
      • Plano, Texas, United States, 75093
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23464
        • Coastal Podiatry, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • Madison Skin and Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active drug
Drug: NAB001
nail lacquer, once daily, 52 weeks
Placebo Comparator: Vehicle alone
Drug: Placebo control
nail lacquer, once daily, 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 56 after 52 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Promius Pharma, LLC

Investigators

  • Study Director: Kent Allenby, MD, Promius Pharma
  • Study Director: Joanne Fraser, PhD, Promius Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0903 (Adult Brain Tumor Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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