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

Primary Purpose

Onychomycosis of Toenails

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AN2690 Topical Solution, 5%
Solution Vehicle
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis of Toenails focused on measuring Onychomycosis, nail fungus, toenail fungus, fungal nail, hyperkeratosis, nail infection, nail treatment, toenail infection, toenail treatment, foot dermatoses, fungal culture, onycholysis, podiatrist, podiatry, subungual, tinea unguium, antifungal, anti-fungal, dermatologist, dermatology, dermatophyte, distal subungual onychomycosis, yellow nail, thick nail, brittle nail, crumbling nail, discolored nail, weak nail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AN2690 Topical Solution, 5%

Solution Vehicle

Arm Description

AN2690 Topical Solution, 5%

Solution Vehicle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Negative Mycology of Target Great Toenail at Week 52
Negative KOH and negative fungal culture.

Full Information

First Posted
January 3, 2011
Last Updated
February 6, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01270971
Brief Title
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2010 (Actual)
Primary Completion Date
November 30, 2012 (Actual)
Study Completion Date
January 8, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenails
Keywords
Onychomycosis, nail fungus, toenail fungus, fungal nail, hyperkeratosis, nail infection, nail treatment, toenail infection, toenail treatment, foot dermatoses, fungal culture, onycholysis, podiatrist, podiatry, subungual, tinea unguium, antifungal, anti-fungal, dermatologist, dermatology, dermatophyte, distal subungual onychomycosis, yellow nail, thick nail, brittle nail, crumbling nail, discolored nail, weak nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
594 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AN2690 Topical Solution, 5%
Arm Type
Experimental
Arm Description
AN2690 Topical Solution, 5%
Arm Title
Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
Solution Vehicle
Intervention Type
Drug
Intervention Name(s)
AN2690 Topical Solution, 5%
Intervention Description
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Solution Vehicle
Intervention Description
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
Primary Outcome Measure Information:
Title
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Description
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 Outcome Measure Information:
Title
Completely Clear or Almost Clear Target Great Toenail at Week 52
Description
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
Title
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Description
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.
Time Frame
Week 52
Title
Negative Mycology of Target Great Toenail at Week 52
Description
Negative KOH and negative fungal culture.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PfizerCT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Investigational Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21214
Country
United States
Facility Name
Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Investigational Site
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Investigational Site
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.toenailstudy.com
Description
To obtain further information about a study center near you, click here to visit www.toenailstudy.com

Learn more about this trial

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

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