Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoBio Corporation
ClinicalTrials.gov Identifier:
NCT00453271
First received: March 26, 2007
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: NB-002
Drug: Vehicle control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by NanoBio Corporation:

Primary Outcome Measures:
  • Planimetry assessment of the target great toenail [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Rate of complete cure [ Time Frame: Week 46 ] [ Designated as safety issue: No ]
  • Rate of therapeutic success [ Time Frame: Week 46 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's visual assessment of length of new unaffected nail [ Designated as safety issue: No ]
  • The presence/absence of DSO on all toenails [ Designated as safety issue: No ]

Enrollment: 443
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453271

  Show 24 Study Locations
Sponsors and Collaborators
NanoBio Corporation
Investigators
Principal Investigator: Alicia Barba, MD International Dermatology Research
Principal Investigator: Alicia Bucko, DO Academic Dermatology Associates
Principal Investigator: Richard Pollak, DPM, MS Endeavor Clinical Trials, PA
Principal Investigator: Michael Jarratt, MD DermResearch Inc.
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: Phoebe Rich, MD Oregon Dermatology and Research Center
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: Wayne Gulliver, MD Newlab Clinical Research Inc.
Principal Investigator: R G Sibbald, MD Dermatology Clinic
  More Information

No publications provided

Responsible Party: NanoBio Corporation
ClinicalTrials.gov Identifier: NCT00453271     History of Changes
Other Study ID Numbers: NB-002-002
Study First Received: March 26, 2007
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by NanoBio Corporation:
chronic persistent infection of the nail bed or plate

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014