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Sponsored by: |
Anacor Pharmaceuticals, Inc. |
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Information provided by: | Anacor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00759161 |
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
Condition | Intervention | Phase |
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Psoriasis |
Drug: AN2728 Drug: AN2728 Ointment Vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis |
Enrollment: | 35 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
AN2728 Ointment, 5%
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Drug: AN2728
AN2728 Ointment, 5%, twice daily for 4 weeks
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2: Placebo Comparator
AN2728 Ointment Vehicle
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Drug: AN2728 Ointment Vehicle
AN2728 Ointment Vehicle, twice daily for 4 weeks.
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This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Two target plaques of similar severity
Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk.
Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
Exclusion Criteria:
Washout periods of:
Responsible Party: | Anacor Pharmaceuticals, Inc. ( Karl Beutner, MD, PhD ) |
Study ID Numbers: | AN2728-PSR-201 |
Study First Received: | September 23, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00759161 History of Changes |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health |
Plaque Type Psoriasis Topical |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |