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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302119
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : August 15, 2014
Last Update Posted : April 3, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 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 : February 2011
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : February 20, 2013

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.



Information from the National Library of Medicine

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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): NCT01302119


Locations
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United States, Arizona
Investigational Site
Phoenix, Arizona, United States, 85050
United States, California
Investigational Site
Novato, California, United States, 94945
Investigational Site
Oceanside, California, United States, 92056
Investigational Site
San Diego, California, United States, 92123
Investigational Site
San Francisco, California, United States, 94115
Investigational Site
Santa Rosa, California, United States, 95405
United States, Florida
Investigational Site
Miami, Florida, United States, 33144
Investigational Site
Miami, Florida, United States, 33175
United States, Idaho
Investigational Site
Nampa, Idaho, United States, 83642
United States, Indiana
Investigational Site
Evansville, Indiana, United States, 47714
United States, Michigan
Investigational Site
Ann Arbor, Michigan, United States, 48103
United States, Missouri
Investigational Site
Saint Louis, Missouri, United States, 63117
United States, New Jersey
Investigational Site
Verona, New Jersey, United States, 07044
United States, New Mexico
Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Investigational Site
High Point, North Carolina, United States, 27262
Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Investigational Site
Columbus, Ohio, United States, 43212
United States, Oregon
Investigational Site
Portland, Oregon, United States, 97223
United States, Pennsylvania
Investigational Site
Philadelphia, Pennsylvania, United States, 19103
United States, South Carolina
Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
Investigational Site
Dallas, Texas, United States, 75243
Investigational Site
San Antonio, Texas, United States, 78209
United States, Utah
Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Virginia
Investigational Site
Harrisonburg, Virginia, United States, 22801
Investigational Site
Norfolk, Virginia, United States, 23507
Canada, Ontario
Investigational Site
Barrie, Ontario, Canada, L4M6L2
Investigational Site
Markham, Ontario, Canada, L3P1A8
Investigational Site
North Bay, Ontario, Canada, P1B3Z7
Canada, Quebec
Investigational Site
Boucherville, Quebec, Canada, J4B5E4
Investigational Site
Montreal, Quebec, Canada, H2K4L5
Canada
Investigational Site
Quebec, Canada, G1V4X7
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: PfizerCT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302119    
Other Study ID Numbers: AN2690-ONYC-302
First Posted: February 23, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: April 3, 2019
Last Verified: March 2019
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:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Tavaborole
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents