Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

May 15, 2013 updated by: NanoBio Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
443

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Planimetry assessment of the target great toenail
Time Frame: Week 24
Week 24
Rate of complete cure
Time Frame: Week 46
Week 46
Rate of therapeutic success
Time Frame: Week 46
Week 46

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NanoBio Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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