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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01208168
First received: September 20, 2010
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Onychomycosis
 Drug: NAB001
Drug: Vehicle alone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Wks

Further study details as provided by Promius Pharma, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 468
Study Start Date: September 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active drug Drug: NAB001
nail lacquer, once daily, 52 weeks
Placebo Comparator: Vehicle alone Drug: Vehicle alone
nail lacquer, once daily, 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208168

  Show 24 Study Locations
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
Study Director: Kent Allenby, MD Promius Pharma
Study Director: Joanne Fraser, PhD Promius Pharma
  More Information

No publications provided

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT01208168     History of Changes
Other Study ID Numbers: 0904
Study First Received: September 20, 2010
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Promius Pharma, LLC:
toenail fungus
onychomycosis
nail infection

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013