Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453271
• Other study ID #: NB-002-002
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2007
• Last updated: May 15, 2013
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2013
• Source: NanoBio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• NB-002

• Vehicle control

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Eastern Canada Cutaneous Research Associates, LTD	Halifax	Nova Scotia
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Lynderm Research, Inc.	Markham	Ontario
Canada	Dermatology Clinic	Mississauga	Ontario
Canada	Innovaderm Research, Inc.	Montreal	Quebec
Canada	International Dermatology Research, Inc.	Montreal	Quebec
Canada	EntraLogix Clinical Group, Inc.	Oakville	Ontario
Canada	Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ)	Quebec
Canada	Newlab Clinical Research, Inc.	St. John's	Newfoundland and Labrador
Canada	K. Papp Clinical Research	Waterloo	Ontario
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch Inc.	Austin	Texas
United States	Northwest Clinical Trial	Boise	Idaho
United States	J & S Studies, Inc.	Bryan	Texas
United States	Michigan Center for Research Corp.	Clinton Township	Michigan
United States	Welborne Clinic	Evansville	Indiana
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	International Dermatology Research	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Endeavor Clinical Trials, PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NanoBio Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Planimetry assessment of the target great toenail		Week 24	No
Primary	Rate of complete cure		Week 46	No
Primary	Rate of therapeutic success		Week 46	No
Secondary	Investigator's visual assessment of length of new unaffected nail			No
Secondary	The presence/absence of DSO on all toenails			No