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Sponsored by: |
Anacor Pharmaceuticals, Inc. |
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Information provided by: | Anacor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00680160 |
The purpose of the study is to determine the absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: AN2690 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label, Multiple-Dose Study of the Absorption and Systemic Pharmacokinetics of AN2690 Applied as a 7.5% Solution to All Toenails of Adult Patients With Moderate to Severe Onychomycosis |
Enrollment: | 15 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:
Has not undergone the specified washout period(s) for the following systemic medications or does the subject require the concurrent use of any of the following systemic medications:
Responsible Party: | Anacor Pharmaceuticals, Inc. ( Karl Beutner, MD, PhD, Chief Medical Officer ) |
Study ID Numbers: | AN2690-ONYC-202 |
Study First Received: | May 15, 2008 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00680160 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Onychomycosis Fungal Nail |
Mycoses Skin Diseases, Infectious Onychomycosis |
Skin Diseases Tinea Dermatomycoses |
Mycoses Skin Diseases, Infectious Nail Diseases Onychomycosis |
Skin Diseases Infection Tinea Dermatomycoses |