Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: NB-002; Drug: Vehicle control

• Registration Number: NCT00453271
• Lead Sponsor: NanoBio Corporation

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-26
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-28
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-05
• Disposition First Submitted: 2013-05-15
• Disposition First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Disposition First Posted: 2013-05-23
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NB-002 0.25% BID	NB-002	-
NB-002 0.5% QD	NB-002	-
NB-002 0.5% BID	NB-002	-
Vehicle control	Vehicle control	-

Primary Outcome Measures

Name	Time	Method
Planimetry assessment of the target great toenail	Week 24
Rate of complete cure	Week 46
Rate of therapeutic success	Week 46

Secondary Outcome Measures

Name	Time	Method
Investigator's visual assessment of length of new unaffected nail
The presence/absence of DSO on all toenails

Trial Locations

Locations (24)

International Dermatology Research; 🇺🇸 Miami, Florida, United States

Northwest Clinical Trial; 🇺🇸 Boise, Idaho, United States

Lynderm Research, Inc.; 🇨🇦 Markham, Ontario, Canada

Newlab Clinical Research, Inc.; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Oregon Medical Research Center, PC; 🇺🇸 Portland, Oregon, United States

J & S Studies, Inc.; 🇺🇸 Bryan, Texas, United States

Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ); 🇨🇦 Quebec, Canada

K. Papp Clinical Research; 🇨🇦 Waterloo, Ontario, Canada

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Dermatology Research Center, Inc.; 🇺🇸 Salt Lake City, Utah, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

EntraLogix Clinical Group, Inc.; 🇨🇦 Oakville, Ontario, Canada

Eastern Canada Cutaneous Research Associates, LTD; 🇨🇦 Halifax, Nova Scotia, Canada

Dermatology Clinic; 🇨🇦 Mississauga, Ontario, Canada

Ultranova Skincare; 🇨🇦 Barrie, Ontario, Canada

The Guenther Dermatology Research Centre; 🇨🇦 London, Ontario, Canada

International Dermatology Research, Inc.; 🇨🇦 Montreal, Quebec, Canada

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

DermResearch Inc.; 🇺🇸 Austin, Texas, United States

Michigan Center for Research Corp.; 🇺🇸 Clinton Township, Michigan, United States

Innovaderm Research, Inc.; 🇨🇦 Montreal, Quebec, Canada

Welborne Clinic; 🇺🇸 Evansville, Indiana, United States

Endeavor Clinical Trials, PA; 🇺🇸 San Antonio, Texas, United States