Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: NB-002; Drug: Vehicle control

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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 4S8
      • NewLab Clinical Research, Inc.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1A4
      • Eastern Canada Cutaneous Research Associates, LTD
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Ultranova Skincare
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research, Inc.
    • Mississauga, Ontario, Canada, L4Y 1A6
      • Dermatology Clinic
    • Oakville, Ontario, Canada, L6K1E1
      • EntraLogix Clinical Group, Inc.
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research, Inc.
    • Montreal, Quebec, Canada, H3H 1U4
      • International Dermatology Research, Inc.
• United States
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trial
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Welborne Clinic
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Research Corp.
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center, Pc
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc.
    • Bryan, Texas, United States, 77802
      • J & S Studies, Inc.
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NB-002 0.25% BID	Drug: NB-002
Experimental: NB-002 0.5% QD	Drug: NB-002
Experimental: NB-002 0.5% BID	Drug: NB-002
Sham Comparator: Vehicle control	Drug: Vehicle control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Planimetry assessment of the target great toenail	Week 24
Rate of complete cure	Week 46
Rate of therapeutic success	Week 46

Secondary Outcome Measures

Outcome Measure
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails

Collaborators and Investigators

• Sponsor: NanoBio Corporation
• Investigators: Principal Investigator: Wayne Gulliver, MD, NewLab Clinical Research Inc.; Principal Investigator: Phoebe Rich, MD, Oregon Dermatology and Research Center; Principal Investigator: Alicia Barba, MD, International Dermatology Research, Inc.; Principal Investigator: Alicia Bucko, DO, Academic Dermatology Associates; Principal Investigator: Richard Pollak, DPM, MS, Endeavor Clinical Trials, PA; Principal Investigator: Terry Jones, MD, J & S Studies, Inc.; Principal Investigator: Robert Kaylor, DPM, Welborne Clinic; Principal Investigator: Steven Kempers, MD, Minnesota Clinical Study Center; Principal Investigator: Robert Matheson, MD, Oregon Medical Research Center, Pc; Principal Investigator: Brock McConnehey,, DO, Northwest Clinical Trial; Principal Investigator: David Pariser, MD, Virginia Clinical Research, Inc.; Principal Investigator: Dan Stewart, DO, Michigan Center for Research Corp; Principal Investigator: Leonard Swinyer, MD, Dermatology Research Center, Inc.; Principal Investigator: Robert Bissonette, MD, Innovaderm Research Inc.; Principal Investigator: Sylvia Garnis-Jones, MD, Entralogix Clinical Group Inc.; Principal Investigator: David Gratton, MD, International Dermatology Research, Inc.; Principal Investigator: Lyn Guenther, MD, The Guenther Dermatology Research Centre; Principal Investigator: Rod Kunynetz, MD, Ultranova Skincare; Principal Investigator: Charles Lynde, MD, Lynderm Research, Inc.; Principal Investigator: Richard Langley, MD, Eastern Canada Cutaneous Research Associates, LTD; Principal Investigator: Kim Papp, MD, K. Papp Clinical Research; Principal Investigator: Yves Poulin, MD, Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ); Principal Investigator: R G Sibbald, MD, Dermatology Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 26, 2007
• First Submitted That Met QC Criteria: March 26, 2007
• First Posted (Estimate): March 28, 2007

Study Record Updates

• Last Update Posted (Estimate): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: chronic persistent infection of the nail bed or plate
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: NB-002-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No