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

NCT01208168 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2013-07-11

No results posted yet for this study

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.

Conditions

  • Onychomycosis

Interventions

DRUG

NAB001

nail lacquer, once daily, 52 weeks

DRUG

Vehicle alone

nail lacquer, once daily, 52 weeks

Sponsors & Collaborators

  • Promius Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Kent Allenby, MD · Promius Pharma

  • Joanne Fraser, PhD · Promius Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01208168 on ClinicalTrials.gov