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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208168
• Other study ID #: 0904
• Status: Terminated
• Phase: Phase 3
• First received: September 20, 2010
• Last updated: July 8, 2013
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Promius Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 468
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• NAB001
nail lacquer, once daily, 52 weeks
• Vehicle alone
nail lacquer, once daily, 52 weeks

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatologica	Santo Domingo
Dominican Republic	Instituto Dermatologico	Santo Domingo
United States	Northwest Clinical Trials	Boise	Idaho
United States	Radiant Research	Cincinnati	Ohio
United States	Ashton Podiatry Associates, PA	Dallas	Texas
United States	Gerard Furst, DPM, PLLC	East Setauket	New York
United States	T. Joseph Raoof, MD, Inc.	Encino	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Carolina Dermatology of Greenville, PA	Greenville	South Carolina
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Internaional Dermatology Research, Inc.	Miami	Florida
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Temple University - School of Podiatric Medicine	Philadelphia	Pennsylvania
United States	Oregon Dermatology & Research Network	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Mazur Foot and Ankle	Salisbury	North Carolina
United States	Progressive Clinical Research	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	Clinical Research Atlanta	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Promius Pharma, LLC

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.		Week 56 after 52 weeks of treatment	No
Secondary	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	No