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Sponsored by: |
Anacor Pharmaceuticals, Inc. |
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Information provided by: | Anacor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00680134 |
The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: AN2690 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 1% and 5% Solutions for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail |
Enrollment: | 60 |
Study Start Date: | June 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group/Cohort 1: Experimental
AN2690 1% Solution (30 subjects)
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Drug: AN2690
AN2690 1% Solution, once daily for 180 days
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Group/Cohort 2: Experimental
AN2690 5% Solution (30 subjects)
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Drug: AN2690
AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days
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The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:
Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143-0517 | |
United States, New Mexico | |
Academic Dermatology Associates | |
Albuquerque, New Mexico, United States, 87106 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Texas | |
DermResearch, Inc. | |
Austin, Texas, United States, 78759 | |
J&S Studies | |
Bryan, Texas, United States, 77802 | |
Endeavor Clinical Trials, PA & San Antonio Podiatry Associates, PC | |
San Antonio, Texas, United States, 78229 |
Study Director: | Karl Beutner, MD, PhD | Anacor Pharmaceuticals, Inc. |
Responsible Party: | Anacor Pharmaceuticals, Inc. ( Karl Beutner, M.D., Ph.D., Chief Medical Officer ) |
Study ID Numbers: | AN2690-ONYC-203 |
Study First Received: | May 15, 2008 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00680134 |
Health Authority: | United States: Food and Drug Administration |
Onychomycosis Fungal Nail |
Mycoses Skin Diseases, Infectious Onychomycosis |
Skin Diseases Tinea Dermatomycoses |
Nail Diseases Infection |