Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Weeks
1 other identifier
interventional
458
1 country
25
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 vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2010
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2010
CompletedFirst Posted
Study publicly available on registry
September 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 11, 2013
July 1, 2013
1.8 years
September 20, 2010
July 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
Week 56 after 52 weeks of treatment
Secondary Outcomes (1)
Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear).
Week 56
Study Arms (2)
Active drug
EXPERIMENTALVehicle alone
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Associated Foot & Ankle Specialists, LLC
Phoenix, Arkansas, 85015, United States
Family Foot Health Center
Rogers, Arkansas, 72758, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
UCSF Dermatology Research
San Francisco, California, 94115, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
North Florida Dermatology Association
Jacksonville, Florida, 32204, United States
Altus Research
Lake Worth, Florida, 33461, United States
Lake Washington Foot and Ankle Center
Melbourne, Florida, 32935, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038, United States
Department of Veteran's Affairs
Minneapolis, Minnesota, 55417, United States
Pinkas Lebovits
New York, New York, 10019, United States
Skin Search of Rochester, Inc.
Rochester, New York, 14623, United States
Care Plus Podiatry, PC
Wading River, New York, 11792, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922, United States
Research Across America
Plano, Texas, 75093, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Dermatology Research Center
Salt Lake City, Utah, 84124, United States
Coastal Podiatry, Inc.
Virginia Beach, Virginia, 23464, United States
Madison Skin and Research, Inc.
Madison, Wisconsin, 53719, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kent Allenby, MD
Promius Pharma
- STUDY DIRECTOR
Joanne Fraser, PhD
Promius Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2010
First Posted
September 23, 2010
Study Start
September 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 11, 2013
Record last verified: 2013-07