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Sponsored by: |
Anacor Pharmaceuticals, Inc. |
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Information provided by: | Anacor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00679523 |
The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: AN2690 Solution, 5.0% Drug: AN2690 Solution, 7.5% |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail |
Enrollment: | 60 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
AN2690 Solution, 5.0%
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Drug: AN2690 Solution, 5.0%
Once daily application for 180 days
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Group 2: Experimental
AN2690 Solution, 7.5%
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Drug: AN2690 Solution, 7.5%
Once daily application for 180 days
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The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30 subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in this study.
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:
Mexico | |
IMIC | |
Mexico City, Mexico | |
Hospital "Dr. Angel Leaño" | |
Guadalajara, Mexico | |
MIRC / OCA Hospital | |
Monterrey, Mexico | |
ISSEMYM | |
Toluca, Mexico | |
Hospital Universitario Dr. José Eleuterio González | |
Monterrey, Mexico | |
CIF-BIOTEC Medica Sur. | |
Mexico City, Mexico | |
Instituto Dermatologico Jalisciense | |
Guadalajara, Mexico | |
Centro Dermatologico Pascua | |
Mexico City, Mexico | |
Unidad de Investigación en Salud (UIS) | |
Chihuahua, Mexico |
Study Director: | Karl Beutner, MD, PhD | Anacor Pharmaceuticals, Inc. |
Responsible Party: | Anacor Pharmaceuticals, Inc. ( Karl Beutner, MD, PhD ) |
Study ID Numbers: | AN2690-ONYC-201 Cohort 1 & 2 |
Study First Received: | May 15, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00679523 |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health |
Onychomycosis Fungal Nail |
Mycoses Skin Diseases, Infectious Onychomycosis |
Skin Diseases Tinea Dermatomycoses |
Nail Diseases Infection |