Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

Onychomycosis of Toenails Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302119
• Other study ID #: AN2690-ONYC-302
• Status: Completed
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: February 20, 2013

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: February 20, 2013
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenails

Intervention

Drug:
• AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
• Solution Vehicle
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Locations

Country	Name	City	State
Canada	Investigational Site	Barrie	Ontario
Canada	Investigational Site	Boucherville	Quebec
Canada	Investigational Site	Markham	Ontario
Canada	Investigational Site	Montreal	Quebec
Canada	Investigational Site	North Bay	Ontario
Canada	Investigational Site	Quebec
United States	Investigational Site	Albuquerque	New Mexico
United States	Investigational Site	Ann Arbor	Michigan
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Evansville	Indiana
United States	Investigational Site	Greer	South Carolina
United States	Investigational Site	Harrisonburg	Virginia
United States	Investigational Site	High Point	North Carolina
United States	Investigational Site	Knoxville	Tennessee
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Miami	Florida
United States	Investigational Site	Nampa	Idaho
United States	Investigational Site	Norfolk	Virginia
United States	Investigational Site	Novato	California
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Phoenix	Arizona
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Raleigh	North Carolina
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Francisco	California
United States	Investigational Site	Santa Rosa	California
United States	Investigational Site	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completely Clear or Almost Clear Target Great Toenail at Week 52	No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over = 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.	Week 52
Secondary	Treatment Success (Completely Clear or Almost 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, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over = 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.	Week 52
Secondary	Negative Mycology of Target Great Toenail at Week 52	Negative KOH and negative fungal culture.	Week 52

External Links

•   To obtain further information about a study center near you, click here to visit www.toenailstudy.com