Clinical trial NCT01270971: Efficacy and Safety Evaluation 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: 2011-01-06
Enrollment: 594
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: Tucson
country: United States
facility: Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Investigational Site
state: Arkansas
city: Burbank
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Orange Park
country: United States
facility: Investigational Site
state: Florida
city: Boise
country: United States
facility: Investigational Site
state: Idaho
city: Evansville
country: United States
facility: Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Fridley
country: United States
facility: Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: New York
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: Rochester
country: United States
facility: Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: South Euclid
country: United States
facility: Investigational Site
state: Ohio
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Providence
country: United States
facility: Investigational Site
state: Rhode Island
city: Germantown
country: United States
facility: Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: College Station
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: PfizerCT.gov Call Center
role: STUDY_DIRECTOR
References: