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

Stopped early · Phase 3

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

NCT01208168

Run by

Promius Pharma, LLC

People needed

468

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
• good general health as assessed by the 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

• Study site — Phoenix, Arkansas, United States
• T. Joseph Raoof, MD, Inc. — Encino, California, United States
• Skin Surgery Medical Group, Inc. — San Diego, California, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Internaional Dermatology Research, Inc. — Miami, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Gerard Furst, DPM, PLLC — East Setauket, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Mazur Foot and Ankle — Salisbury, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States
• Oregon Dermatology & Research Network — Portland, Oregon, United States
• Temple University - School of Podiatric Medicine — Philadelphia, Pennsylvania, United States
• Carolina Dermatology of Greenville, PA — Greenville, South Carolina, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Ashton Podiatry Associates, PA — Dallas, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Instituto Dermatologica — Santo Domingo, Dominican Republic
• Instituto Dermatologico — Santo Domingo, Dominican Republic

Full record on ClinicalTrials.gov

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