Efficacy and Safety Evaluation 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: NCT01270971
• Other study ID #: AN2690-ONYC-301
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2010
• Est. completion date: January 8, 2013

Study information

• Verified date: February 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: 594
• Est. completion date: January 8, 2013
• Est. primary completion date: November 30, 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
United States	Investigational Site	Austin	Texas
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Boise	Idaho
United States	Investigational Site	Burbank	California
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	College Station	Texas
United States	Investigational Site	Denver	Colorado
United States	Investigational Site	Evansville	Indiana
United States	Investigational Site	Fridley	Minnesota
United States	Investigational Site	Germantown	Tennessee
United States	Investigational Site	Hot Springs	Arkansas
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Lynchburg	Virginia
United States	Investigational Site	New York	New York
United States	Investigational Site	New York	New York
United States	Investigational Site	Omaha	Nebraska
United States	Investigational Site	Orange Park	Florida
United States	Investigational Site	Overland Park	Kansas
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Providence	Rhode Island
United States	Investigational Site	Rochester	New York
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	San Francisco	California
United States	Investigational Site	South Euclid	Ohio
United States	Investigational Site	Spokane	Washington
United States	Investigational Site	Tucson	Arizona
United States	Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

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