- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208168
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
July 8, 2013 updated by: Promius Pharma, LLC
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 Wks
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
468
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santo Domingo, Dominican Republic
- Instituto Dermatológico
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Santo Domingo, Dominican Republic
- Instituto Dermatologica
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Arkansas
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Phoenix, Arkansas, United States, 85032
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California
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Encino, California, United States, 91436
- T. Joseph Raoof, MD, Inc.
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San Diego, California, United States, 92117
- Skin Surgery Medical Group, Inc.
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Colorado
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Longmont, Colorado, United States, 80501
- Longmont Medical Research Network
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Florida
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Miami, Florida, United States, 33144
- Internaional Dermatology Research, Inc.
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Georgia
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Newnan, Georgia, United States, 30263
- MedaPhase, Inc.
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
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Idaho
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Boise, Idaho, United States, 83704
- Northwest Clinical Trials
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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New York
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East Setauket, New York, United States, 11733
- Gerard Furst, DPM, PLLC
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North Carolina
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High Point, North Carolina, United States, 27262
- Dermatology Consulting Services
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Salisbury, North Carolina, United States, 28144
- Mazur Foot and Ankle
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Ohio
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Cincinnati, Ohio, United States, 45249
- Radiant Research
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Oregon
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Portland, Oregon, United States, 97210
- Oregon Dermatology & Research Network
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Temple University - School of Podiatric Medicine
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South Carolina
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Greenville, South Carolina, United States, 29681
- Carolina Dermatology of Greenville, PA
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Mt. Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center
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Tennessee
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Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
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Texas
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Dallas, Texas, United States, 75243
- Ashton Podiatry Associates, PA
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San Antonio, Texas, United States, 78229
- Progressive Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active drug
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nail lacquer, once daily, 52 weeks
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Placebo Comparator: Vehicle alone
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nail lacquer, once daily, 52 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
Time Frame: Week 56 after 52 weeks of treatment
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Week 56 after 52 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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).
Time Frame: Week 56
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Week 56
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kent Allenby, MD, Promius Pharma
- Study Director: Joanne Fraser, PhD, Promius Pharma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
September 20, 2010
First Submitted That Met QC Criteria
September 22, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Estimate)
July 11, 2013
Last Update Submitted That Met QC Criteria
July 8, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0904 (Other Grant/Funding Number: Landsteiner Foundation for Blood Transfusion Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on NAB001
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