Psoriasis Clinical Trial
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
Summary
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
at least two evaluable plaques with CPSS >/= 6
baseline PSGA >/= 2
women of childbearing potential msut agree to use an effective form of contraception
Exclusion Criteria:
cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
cannot have concomitant serious illness/condition that may interfere with participation in the study
cannot have used topical therapy within 2 weeks prior to baseline visit
cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
cannot have a history of hypercalcemia or kidney stones
cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
cannot be pregnant or a nursing mother
cannot be participating in or have participated in an interventional study within 30 days of study start
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There are 16 Locations for this study
Tucson Arizona, 85710, United States
Little Rock Arkansas, 72205, United States
Chicago Illinois, 60611, United States
Overland Park Kansas, 66215, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10016, United States
New York New York, 10029, United States
Williamsville New York, 14221, United States
Winston-Salem North Carolina, 27157, United States
Cincinatti Ohio, 45249, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19103, United States
Anderson South Carolina, 29621, United States
Greenville South Carolina, 29607, United States
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