Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Onychomycosis

In brief

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Key facts

Study ID

NCT01208129

Run by

Promius Pharma, LLC

People needed

458

Starts

2010-09-01

Expected to finish

2012-07-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• mild to moderate fungal infection of the toenail as assessed by study doctor
• koh positive \& dermatophyte culture positive at Visit 1
• general good health as assessed by study doctor

You may not qualify if…

• severe fungal toenail infection
• prior use of antifungal drugs (wash-out allowed, duration varies on class)
• significant confounding conditions as assessed by study doctor
• pregnancy/lactation
• must forego nail salon procedures during study for at least \~60 weeks

Where it is running

• Radiant Research, Inc. — Tucson, Arizona, United States
• Associated Foot & Ankle Specialists, LLC — Phoenix, Arkansas, United States
• Family Foot Health Center — Rogers, Arkansas, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• UCSF Dermatology Research — San Francisco, California, United States
• Avail Clinical Research — DeLand, Florida, United States
• North Florida Dermatology Association — Jacksonville, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Lake Washington Foot and Ankle Center — Melbourne, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Department of Veteran's Affairs — Minneapolis, Minnesota, United States
• Pinkas Lebovits — New York, New York, United States
• Skin Search of Rochester, Inc. — Rochester, New York, United States
• Care Plus Podiatry, PC — Wading River, New York, United States
• Oregon Medical Research Center, PC — Portland, Oregon, United States
• Radiant Research, Inc. — Greer, South Carolina, United States
• The Skin Wellness Center, PC — Knoxville, Tennessee, United States
• Research Across America — Plano, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States
• Dermatology Research Center — Salt Lake City, Utah, United States
• Coastal Podiatry, Inc. — Virginia Beach, Virginia, United States
• Madison Skin and Research, Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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