Journal of Clinical & Experimental Dermatology Research
Open Access

Victoria P. Werth

Publications

• Research
  Design Considerations for Clinical Trials Using the Cutaneous Dermatomyositis Disease Area and Severity Index as a Primary Endpoint
  Author(s): Julie A. Brevard, Mark Hurtt, Joanna Horobin, Olga Polyanskaya, James Baker, Victoria P. Werth, David F. FiorentinoJulie A. Brevard, Mark Hurtt, Joanna Horobin, Olga Polyanskaya, James Baker, Victoria P. Werth, David F. Fiorentino
  
  Objective: Skin inflammation is a universal characteristic of the multisystem inflammatory myopathy dermatomyositis (DM). About 35% of DM patients have a polycyclic or chronic disease course, usually due to active skin disease, despite standard of care therapy, demonstrating a significant unmet need for novel treatment options. To test the efficacy of novel therapeutics, feasible prospective clinical trials must be designed that employ quantitative endpoints. The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a validated, reliable, and responsive measurement of cutaneous DM disease activity and damage. The primary objectives were to identify requisite design parameters (e.g., target trial population, duration, frequency of assessments, treatment difference, sample size) for a proofofconcept clinical trial of a novel therapy in patients with DM... View More»
  DOI: 10.4172/2155-9554.1000401

  Abstract PDF

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