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This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study.
All subjects with stable psoriatic plaques will receive all of the following treatments each in a separate test field, once each day for four weeks under occlusion:
- CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
- CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
- 0.1% nortriptyline HCl topical cream
- 0.005% calcipotriol topical cream
- Vehicle of CRx-197 topical cream (placebo)
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
CRx-197, CRx-197, Nortriptyline, Calcipotriol, Placebo
Published on BioPortfolio: 2014-08-27T03:26:06-0400
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A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.
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