NCT01208168

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

24 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

September 20, 2010

Last Update Submit

July 8, 2013

Conditions

Onychomycosis

Keywords

toenail fungusonychomycosisnail infection

Outcome Measures

Primary Outcomes (1)

  • Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.

    Week 56 after 52 weeks of treatment

Secondary Outcomes (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).

    Week 56

Study Arms (2)

Active drug

EXPERIMENTAL
Drug: NAB001

Vehicle alone

PLACEBO COMPARATOR
Drug: Vehicle alone

Interventions

NAB001DRUG

nail lacquer, once daily, 52 weeks

Active drug
Vehicle aloneDRUG

nail lacquer, once daily, 52 weeks

Vehicle alone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Phoenix, Arkansas, 85032, United States

Location

T. Joseph Raoof, MD, Inc.

Encino, California, 91436, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Internaional Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Gerard Furst, DPM, PLLC

East Setauket, New York, 11733, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Mazur Foot and Ankle

Salisbury, North Carolina, 28144, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Oregon Dermatology & Research Network

Portland, Oregon, 97210, United States

Location

Temple University - School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Carolina Dermatology of Greenville, PA

Greenville, South Carolina, 29681, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Ashton Podiatry Associates, PA

Dallas, Texas, 75243, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Instituto Dermatologica

Santo Domingo, Dominican Republic

Location

Instituto Dermatologico

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kent Allenby, MD

    Promius Pharma

    STUDY DIRECTOR

  • Joanne Fraser, PhD

    Promius Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 23, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(22)DO(2)