Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
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
1 other identifier
interventional
594
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2013
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedFebruary 22, 2019
February 1, 2019
2 years
January 3, 2011
July 25, 2014
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Week 52
Secondary Outcomes (3)
Completely Clear or Almost Clear Target Great Toenail at Week 52
Week 52
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Week 52
Negative Mycology of Target Great Toenail at Week 52
Week 52
Study Arms (2)
AN2690 Topical Solution, 5%
EXPERIMENTALAN2690 Topical Solution, 5%
Solution Vehicle
PLACEBO COMPARATORSolution Vehicle
Interventions
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Investigational Site
Tucson, Arizona, 85741, United States
Investigational Site
Hot Springs, Arkansas, 71913, United States
Investigational Site
Burbank, California, 91505, United States
Investigational Site
Los Angeles, California, 90045, United States
Investigational Site
San Francisco, California, 94115, United States
Investigational Site
Denver, Colorado, 80210, United States
Investigational Site
Orange Park, Florida, 32073, United States
Investigational Site
Boise, Idaho, 83686, United States
Investigational Site
Evansville, Indiana, 47713, United States
Investigational Site
Overland Park, Kansas, 66202, United States
Investigational Site
Baltimore, Maryland, 21214, United States
Investigational Site
Fridley, Minnesota, 55432, United States
Investigational Site
Omaha, Nebraska, 68144, United States
Investigational Site
New York, New York, 10011, United States
Investigational Site
New York, New York, 10155, United States
Investigational Site
Rochester, New York, 14623, United States
Investigational Site
Winston-Salem, North Carolina, 27157, United States
Investigational Site
Cincinnati, Ohio, 45249, United States
Investigational Site
South Euclid, Ohio, 44118, United States
Investigational Site
Portland, Oregon, 97210, United States
Investigational Site
Providence, Rhode Island, 02920, United States
Investigational Site
Germantown, Tennessee, 38138, United States
Investigational Site
Austin, Texas, 78759, United States
Investigational Site
College Station, Texas, 77845, United States
Investigational Site
San Antonio, Texas, 78229, United States
Investigational Site
Lynchburg, Virginia, 24501, United States
Investigational Site
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sheryl Baldwin, RN/Associate Director
- Organization
- Anacor Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
PfizerCT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 6, 2011
Study Start
December 1, 2010
Primary Completion
November 30, 2012
Study Completion
January 8, 2013
Last Updated
February 22, 2019
Results First Posted
August 15, 2014
Record last verified: 2019-02