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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01302119
First received: February 21, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Negative KOH and negative fungal culture.


Enrollment: 604
Study Start Date: February 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302119

  Hide Study Locations
Locations
United States, Arizona
Anacor Investigational Site
Phoenix, Arizona, United States, 85050
United States, California
Anacor Investigational Site
Novato, California, United States, 94945
Anacor Investigational Site
Oceanside, California, United States, 92056
Anacor Investigational Site
San Diego, California, United States, 92123
Anacor Investigational Site
San Francisco, California, United States, 94115
Anacor Investigational Site
Santa Rosa, California, United States, 95405
United States, Florida
Anacor Investigational Site
Miami, Florida, United States, 33144
Anacor Investigational Site
Miami, Florida, United States, 33175
United States, Idaho
Anacor Investigational Site
Nampa, Idaho, United States, 83642
United States, Indiana
Anacor Investigational Site
Evansville, Indiana, United States, 47714
United States, Michigan
Anacor Investigational Site
Ann Arbor, Michigan, United States, 48103
United States, Missouri
Anacor Investigational Site
St. Louis, Missouri, United States, 63117
United States, New Jersey
Anacor Investigational Site
Verona, New Jersey, United States, 07044
United States, New Mexico
Anacor Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Anacor Investigational Site
High Point, North Carolina, United States, 27262
Anacor Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Anacor Investigational Site
Columbus, Ohio, United States, 43212
United States, Oregon
Anacor Investigational Site
Portland, Oregon, United States, 97223
United States, Pennsylvania
Anacor Investigational Site
Philadelphia, Pennsylvania, United States, 19103
United States, South Carolina
Anacor Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Anacor Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
Anacor Investigational Site
Dallas, Texas, United States, 75243
Anacor Investigational Site
San Antonio, Texas, United States, 78209
United States, Utah
Anacor Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Virginia
Anacor Investigational Site
Harrisonburg, Virginia, United States, 22801
Anacor Investigational Site
Norfolk, Virginia, United States, 23507
Canada, Ontario
Anacor Investigational Site
Barrie, Ontario, Canada, L4M6L2
Anacor Investigational Site
Markham, Ontario, Canada, L3P1A8
Anacor Investigational Site
North Bay, Ontario, Canada, P1B3Z7
Canada, Quebec
Anacor Investigational Site
Boucherville, Quebec, Canada, J4B5E4
Anacor Investigational Site
Montreal, Quebec, Canada, H2K4L5
Canada
Anacor Investigational Site
Quebec, Canada, G1V4X7
Sponsors and Collaborators
Anacor Pharmaceuticals, Inc.
Investigators
Study Director: Lee Zane, MD, MAS Anacor Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01302119     History of Changes
Other Study ID Numbers: AN2690-ONYC-302
Study First Received: February 21, 2011
Results First Received: July 25, 2014
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Anacor Pharmaceuticals, Inc.:
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
Dermatomycoses
Infection
Mycoses
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Tinea
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014