Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

NCT00453271 | Completed Phase 2

• 1 other identifier: NB-002-002
• Study Type: interventional
• Target: 443
• Locations: 2 countries
• Sites: 24

Brief Summary

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.

Conditions

Onychomycosis

Keywords

chronic persistent infection of the nail bed or plate

Outcome Measures

Primary Outcomes (3)

• Planimetry assessment of the target great toenail

  Week 24

• Rate of complete cure

  Week 46

• Rate of therapeutic success

  Week 46

Secondary Outcomes (2)

• Investigator's visual assessment of length of new unaffected nail

• The presence/absence of DSO on all toenails

Study Arms (4)

NB-002 0.25% BID

EXPERIMENTAL

Drug: NB-002

NB-002 0.5% QD

EXPERIMENTAL

Drug: NB-002

NB-002 0.5% BID

EXPERIMENTAL

Drug: NB-002

Vehicle control

SHAM COMPARATOR

Drug: Vehicle control

Interventions

NB-002 DRUG

NB-002 0.25% BID; NB-002 0.5% BID; NB-002 0.5% QD

Vehicle control DRUG

Vehicle control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• NanoBio Corporation: lead

Study Sites (24)

International Dermatology Research

Miami, Florida, 33144, United States

Location

Northwest Clinical Trial

Boise, Idaho, 83704, United States

Location

Welborne Clinic

Evansville, Indiana, 47713, United States

Location

Michigan Center for Research Corp.

Clinton Township, Michigan, 48038, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

Bryan, Texas, 77802, United States

Location

Endeavor Clinical Trials, PA

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84124, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Newlab Clinical Research, Inc.

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Eastern Canada Cutaneous Research Associates, LTD

Halifax, Nova Scotia, B3H 1A4, Canada

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research, Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Dermatology Clinic

Mississauga, Ontario, L4Y 1A6, Canada

Location

EntraLogix Clinical Group, Inc.

Oakville, Ontario, L6K1E1, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Innovaderm Research, Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

International Dermatology Research, Inc.

Montreal, Quebec, H3H 1U4, Canada

Location

Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)

Québec, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

• Michael Jarratt, MD

  Derm Research, PLLC

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

CA (11); US (13)