Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Completed · Phase 2

Conditions studied: Onychomycosis

In brief

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.

Key facts

Study ID

NCT00453271

Run by

NanoBio Corporation

People needed

443

Starts

2007-01-01

Expected to finish

2008-10-01

Last updated by the study team

2013-05-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

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

Full record on ClinicalTrials.gov

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