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

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ClinicalTrials.gov Identifier: NCT01208129
Recruitment Status : Terminated
First Posted : September 23, 2010
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: NAB001 Drug: Placebo control Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active drug Drug: NAB001
nail lacquer, once daily, 52 weeks
Placebo Comparator: Vehicle alone Drug: Placebo control
nail lacquer, once daily, 52 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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). [ Time Frame: Week 56 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208129


Locations
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Sponsors and Collaborators
Promius Pharma, LLC
Investigators
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Study Director: Kent Allenby, MD Promius Pharma
Study Director: Joanne Fraser, PhD Promius Pharma
More Information
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Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT01208129    
Other Study ID Numbers: 0903
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Promius Pharma, LLC:
toenail fungus
onychomycosis
nail infection
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases