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

Pfizer1 site in 1 country594 target enrollmentDecember 1, 2010

ConditionsOnychomycosis of Toenails

InterventionsAN2690 Topical Solution, 5%Solution Vehicle

DrugsAN2690 Topical Solution, 5%Solution Vehicle

Overview

Phase: Phase 3
Intervention: AN2690 Topical Solution, 5%
Conditions: Onychomycosis of Toenails
Sponsor: Pfizer
Enrollment: 594
Locations: 1
Primary Endpoint: Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2010

End Date

January 8, 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

AN2690 Topical Solution, 5%

Intervention: AN2690 Topical Solution, 5%

Solution Vehicle

Intervention: Solution Vehicle

Outcomes

Primary Outcomes

Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52

Time Frame: 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.

Secondary Outcomes

Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52(Week 52)
Completely Clear or Almost Clear Target Great Toenail at Week 52(Week 52)
Negative Mycology of Target Great Toenail at Week 52(Week 52)