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

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ClinicalTrials.gov Identifier: NCT01270971
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenails Drug: AN2690 Topical Solution, 5% Drug: Solution Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2010
Actual Primary Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tavaborole

Arm Intervention/treatment
Experimental: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%
Drug: AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Placebo Comparator: Solution Vehicle
Solution Vehicle
Drug: Solution Vehicle
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Negative Mycology of Target Great Toenail at Week 52 [ Time Frame: Week 52 ]
    Negative KOH and negative fungal culture.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270971


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270971     History of Changes
Other Study ID Numbers: AN2690-ONYC-301
First Posted: January 6, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: July 2014

Keywords provided by Pfizer:
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

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Tavaborole
Antifungal Agents
Anti-Infective Agents