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

NCT ID: NCT01270971

Last Updated: 2019-02-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-01

Study Completion Date

2013-01-08

Brief Summary

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

Detailed Description

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Conditions

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Onychomycosis of Toenails

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%

Group Type EXPERIMENTAL

AN2690 Topical Solution, 5%

Intervention Type DRUG

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

Solution Vehicle

Solution Vehicle

Group Type PLACEBO_COMPARATOR

Solution Vehicle

Intervention Type DRUG

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

Interventions

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AN2690 Topical Solution, 5%

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

Intervention Type DRUG

Solution Vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PfizerCT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Investigational Site

Tucson, Arizona, United States

Site Status

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Hot Springs, Arkansas, United States

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Burbank, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Orange Park, Florida, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Overland Park, Kansas, United States

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Baltimore, Maryland, United States

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Fridley, Minnesota, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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South Euclid, Ohio, United States

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Portland, Oregon, United States

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Providence, Rhode Island, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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College Station, Texas, United States

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San Antonio, Texas, United States

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Lynchburg, Virginia, United States

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Spokane, Washington, United States

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Countries

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United States

Other Identifiers

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AN2690-ONYC-301

Identifier Type: -

Identifier Source: org_study_id

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