Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
- Conditions
- Psoriasis
- Registration Number
- NCT00384098
- Lead Sponsor
- OPKO Health, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
- Secondary Outcome Measures
Name Time Method Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
Trial Locations
- Locations (15)
Radiant Research Inc.
🇺🇸Anderson, South Carolina, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
New York University Medical Center
🇺🇸New York, New York, United States
Radiant Research, Kansas City
🇺🇸Overland Park, Kansas, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Dermatology Research of Arkansas PLLC
🇺🇸Little Rock, Arkansas, United States
Palmetto Clinical Trial Services LLC
🇺🇸Greenville, South Carolina, United States
UMDNJ-Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Mass General/ Brigham & Women's
🇺🇸Boston, Massachusetts, United States
Paddington Testing Co.
🇺🇸Philadelphia, Pennsylvania, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Buffalo Medical Group PC
🇺🇸Williamsville, New York, United States
Department of Dermatology, Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Radiant Research
🇺🇸Cincinatti, Ohio, United States