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

February 6, 2019 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

594

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Investigational Site
    • California
      • Burbank, California, United States, 91505
        • Investigational Site
      • Los Angeles, California, United States, 90045
        • Investigational Site
      • San Francisco, California, United States, 94115
        • Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Investigational Site
    • Florida
      • Orange Park, Florida, United States, 32073
        • Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83686
        • Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21214
        • Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Investigational Site
    • New York
      • New York, New York, United States, 10011
        • Investigational Site
      • New York, New York, United States, 10155
        • Investigational Site
      • Rochester, New York, United States, 14623
        • Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Investigational Site
      • South Euclid, Ohio, United States, 44118
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02920
        • Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Investigational Site
      • College Station, Texas, United States, 77845
        • Investigational Site
      • San Antonio, Texas, United States, 78229
        • Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AN2690 Topical Solution, 5%
Drug: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
Placebo Comparator: Solution Vehicle
Drug: Solution Vehicle
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completely Clear or Almost Clear 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, 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
Treatment Success (Completely Clear or Almost 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, 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
Negative Mycology of Target Great Toenail at Week 52
Time Frame: Week 52
Negative KOH and negative fungal culture.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

November 30, 2012

Study Completion (Actual)

January 8, 2013

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 6, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN2690-ONYC-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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