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

This study has been terminated.
Information provided by (Responsible Party):
Promius Pharma, LLC Identifier:
First received: September 20, 2010
Last updated: July 8, 2013
Last verified: July 2013
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
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 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 ]

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 ]

Enrollment: 468
Study Start Date: September 2010
Study Completion Date: July 2012
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01208168

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

Responsible Party: Promius Pharma, LLC Identifier: NCT01208168     History of Changes
Other Study ID Numbers: 0904
Study First Received: September 20, 2010
Last Updated: July 8, 2013

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

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases processed this record on August 23, 2017