Efficacy and Safety 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
604
2 countries
32
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 Feb 2011
32 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
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 21, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2013
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedApril 3, 2019
March 1, 2019
1.9 years
February 21, 2011
July 25, 2014
March 26, 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 (32)
Investigational Site
Phoenix, Arizona, 85050, United States
Investigational Site
Novato, California, 94945, United States
Investigational Site
Oceanside, California, 92056, United States
Investigational Site
San Diego, California, 92123, United States
Investigational Site
San Francisco, California, 94115, United States
Investigational Site
Santa Rosa, California, 95405, United States
Investigational Site
Miami, Florida, 33144, United States
Investigational Site
Miami, Florida, 33175, United States
Investigational Site
Nampa, Idaho, 83642, United States
Investigational Site
Evansville, Indiana, 47714, United States
Investigational Site
Ann Arbor, Michigan, 48103, United States
Investigational Site
St Louis, Missouri, 63117, United States
Investigational Site
Verona, New Jersey, 07044, United States
Investigational Site
Albuquerque, New Mexico, 87106, United States
Investigational Site
High Point, North Carolina, 27262, United States
Investigational Site
Raleigh, North Carolina, 27612, United States
Investigational Site
Columbus, Ohio, 43212, United States
Investigational Site
Portland, Oregon, 97223, United States
Investigational Site
Philadelphia, Pennsylvania, 19103, United States
Investigational Site
Greer, South Carolina, 29651, United States
Investigational Site
Knoxville, Tennessee, 37922, United States
Investigational Site
Dallas, Texas, 75243, United States
Investigational Site
San Antonio, Texas, 78209, United States
Investigational Site
Salt Lake City, Utah, 84124, United States
Investigational Site
Harrisonburg, Virginia, 22801, United States
Investigational Site
Norfolk, Virginia, 23507, United States
Investigational Site
Barrie, Ontario, L4M6L2, Canada
Investigational Site
Markham, Ontario, L3P1A8, Canada
Investigational Site
North Bay, Ontario, P1B3Z7, Canada
Investigational Site
Boucherville, Quebec, J4B5E4, Canada
Investigational Site
Montreal, Quebec, H2K4L5, Canada
Investigational Site
Québec, G1V4X7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, 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
February 21, 2011
First Posted
February 23, 2011
Study Start
February 1, 2011
Primary Completion
December 31, 2012
Study Completion
February 20, 2013
Last Updated
April 3, 2019
Results First Posted
August 15, 2014
Record last verified: 2019-03