Clinical trial NCT01302119: Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis of Toenails
Keywords: Onychomycosis
nail fungus
toenail fungus
fungal nail
hyperkeratosis
nail infection
nail treatment
toenail infection
toenail treatment
foot dermatoses
fungal culture
onycholysis
podiatrist
podiatry
subungual
tinea unguium
antifungal
anti-fungal
dermatologist
dermatology
dermatophyte
distal subungual onychomycosis
yellow nail
thick nail
brittle nail
crumbling nail
discolored nail
weak nail
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
* KOH positive at screening
* Willingness not to use any other products including nail polish applied to the toenails during the study
* Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
* History of any significant chronic fungal disease other than onychomycosis
* Significant confounding conditions as assessed by study doctor
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation

Primary outcomes:
measure: Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Completely Clear or Almost Clear Target Great Toenail at Week 52
timeFrame: Week 52
measure: Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
timeFrame: Week 52
measure: Negative Mycology of Target Great Toenail at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Novato
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Investigational Site
state: California
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Nampa
country: United States
facility: Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Investigational Site
state: Indiana
city: Ann Arbor
country: United States
facility: Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: Verona
country: United States
facility: Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigational Site
state: New Mexico
city: High Point
country: United States
facility: Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Harrisonburg
country: United States
facility: Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
city: Barrie
country: Canada
facility: Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Investigational Site
state: Ontario
city: Boucherville
country: Canada
facility: Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site
Study officials:
affiliation: Pfizer
name: PfizerCT.gov Call Center
role: STUDY_DIRECTOR
References: