Status:
TERMINATED
Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
Lead Sponsor:
Promius Pharma, LLC
Conditions:
Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 ve...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT01208129
Start Date
September 1 2010
End Date
July 1 2012
Last Update
July 11 2013
Active Locations (25)
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1
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
2
Associated Foot & Ankle Specialists, LLC
Phoenix, Arkansas, United States, 85015
3
Family Foot Health Center
Rogers, Arkansas, United States, 72758
4
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538