Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
This study has been completed.
Sponsor:
Anacor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01302119
First received: February 21, 2011
Last updated: June 11, 2013
Last verified: June 2013
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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 after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Completely clear or almost clear target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Treatment success (completely clear or almost clear nail and negative mycology) of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Negative mycology of target great toenail after 48 weeks of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events and local tolerability signs/symptoms in subjects treated for up to 48 weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302119
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Hide Study LocationsLocations
| 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 |
| Last Updated: | June 11, 2013 |
| 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 Tinea Dermatomycoses Skin Diseases, Infectious |
Infection Mycoses Nail Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013