Status:
COMPLETED
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 saf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00384098
Start Date
September 1 2006
End Date
May 1 2007
Last Update
September 29 2014
Active Locations (16)
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1
Radiant Research
Tucson, Arizona, United States, 85710
2
Dermatology Research of Arkansas PLLC
Little Rock, Arkansas, United States, 72205
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Radiant Research, Kansas City
Overland Park, Kansas, United States, 66215