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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208168
Recruitment Status : Terminated
First Posted : September 23, 2010
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Promius Pharma, LLC

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: Vehicle alone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 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 Wks
Study Start Date : September 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Active drug Drug: NAB001
nail lacquer, once daily, 52 weeks

Placebo Comparator: Vehicle alone Drug: Vehicle alone
nail lacquer, once daily, 52 weeks

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 ]

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): 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

Responsible Party: Promius Pharma, LLC Identifier: NCT01208168     History of Changes
Other Study ID Numbers: 0904
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
nail infection

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases