Clinical trial NCT01208168: Safety & 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 Wks
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: 468
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
* 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

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