Clinical trial NCT01208129: Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: toenail fungus
onychomycosis
nail infection
Lead sponsor: Promius Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
timeFrame: Week 56 after 52 weeks of treatment
Secondary outcomes:
measure: 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).
timeFrame: Week 56
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Associated Foot & Ankle Specialists, LLC
state: Arkansas
city: Rogers
country: United States
facility: Family Foot Health Center
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Dermatology Research
state: California
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Association
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Melbourne
country: United States
facility: Lake Washington Foot and Ankle Center
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Minneapolis
country: United States
facility: Department of Veteran's Affairs
state: Minnesota
city: New York
country: United States
facility: Pinkas Lebovits
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Wading River
country: United States
facility: Care Plus Podiatry, PC
state: New York
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Virginia Beach
country: United States
facility: Coastal Podiatry, Inc.
state: Virginia
city: Madison
country: United States
facility: Madison Skin and Research, Inc.
state: Wisconsin
Study officials:
affiliation: Promius Pharma
name: Kent Allenby, MD
role: STUDY_DIRECTOR
affiliation: Promius Pharma
name: Joanne Fraser, PhD
role: STUDY_DIRECTOR
References: