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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 25, 2007 | ||||||||
| Last Updated Date | December 29, 2008 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
A reduction of an individual's PASI by 75% after five (5) treatments of the active drug (Bicillin L-A). To demonstrate benefit comparable to the currently available biologicals, the response rate of Bicillin L-A must be at least 40% [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
A reduction of an individual's PASI by 75% after five (5) treatments of the active drug (Bicillin L-A). To demonstrate benefit comparable to the currently available biologicals, the response rate of Bicillin L-A must be at least 40% | ||||||||
| Change History | Complete list of historical versions of study NCT00427609 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications | ||||||||
| Official Title ICMJE | Efficacy of Bicillin LA for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications. | ||||||||
| Brief Summary | The purpose of this study is to determine the efficacy for Bicillin L-A, administered intramuscularly in a dose of 2.4 million units every three (3) weeks, for the treatment of chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic therapies are contraindicated. |
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| Detailed Description | Psoriasis is a chronic, inflammatory skin disorder most commonly manifested by well-demarcated, erythematous and/or scaling plaques on the elbows, knees, scalp, and trunk. Psoriasis is a common disease with overall incidence of 1-3% of the general population. The estimated prevalence varies from 1-2%. There is significant geographical variability with the lowest incidence of the disease around the equator and increasing towards the poles. Psoriasis is now considered an autoimmune disease mediated by activated T-cells, releasing proinflammatory cytokines, predominately TNF-a and IFN-y. The key role for T-cells in the pathogenesis of psoriasis was supported by reported beneficial effects of specific T cell targeted therapies including cyclosporin A and certain recently marketed immune response modifiers. While disease pathogenesis is still not completely understood, the factors that may trigger or worsen psoriasis have been systematically studied and well described in the medical literature. Psychological stress, mechanical trauma to the skin, certain medications and Streptococcus strains are the most common disease triggers. It was first reported in 1916 that the onset of psoriasis is often preceded by throat infections with hemolytic streptococci and the role of M-protein positive beta hemolytic streptococci in triggering guttate psoriasis has been confirmed in subsequent studies. Exacerbation of chronic plaque type psoriasis has been reported in association with tonsillitis in retrospective studies. Moreover, high frequency of remission after tonsillectomy or antibiotic treatment has been documented. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Psoriasis | ||||||||
| Intervention ICMJE | Drug: Bicillin L-A | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00427609 | ||||||||
| Responsible Party | Brenda Steen, R.N. Research Nurse Coordinator, University of Tennessee | ||||||||
| Study ID Numbers ICMJE | 8389 | ||||||||
| Study Sponsor ICMJE | University of Tennessee | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Tennessee | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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