Safety and 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 Weeks

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01208129
• Other study ID #: 0903
• 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: 458
• 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

• general good health as assessed by 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
• Placebo control
nail lacquer, once daily, 52 weeks

Locations

Country	Name	City	State
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Avail Clinical Research	DeLand	Florida
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Radiant Research, Inc.	Greer	South Carolina
United States	North Florida Dermatology Association	Jacksonville	Florida
United States	The Skin Wellness Center, PC	Knoxville	Tennessee
United States	Altus Research	Lake Worth	Florida
United States	Madison Skin and Research, Inc.	Madison	Wisconsin
United States	Lake Washington Foot and Ankle Center	Melbourne	Florida
United States	Department of Veteran's Affairs	Minneapolis	Minnesota
United States	Pinkas Lebovits	New York	New York
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Associated Foot & Ankle Specialists, LLC	Phoenix	Arkansas
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Research Across America	Plano	Texas
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Family Foot Health Center	Rogers	Arkansas
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	UCSF Dermatology Research	San Francisco	California
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Coastal Podiatry, Inc.	Virginia Beach	Virginia
United States	Care Plus Podiatry, PC	Wading River	New York

Sponsors (1)

Lead Sponsor	Collaborator
Promius Pharma, LLC

Country where clinical trial is conducted

United States, 

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