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

Pfizer594 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

594

Conditions

Onychomycosis of Toenails

Interventions

AN2690 Topical Solution, 5%DRUG

AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution VehicleDRUG

AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Investigational Site

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 52

Secondary Outcomes

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.

Time frame: Week 52

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

Time frame: Week 52

Negative Mycology of Target Great Toenail at Week 52

Negative KOH and negative fungal culture.

Time frame: Week 52

Data from ClinicalTrials.gov

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