Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

Completed · Phase 2

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT00384098

Run by

OPKO Health, Inc.

People needed

140

Starts

2006-09-01

Expected to finish

2007-05-01

Last updated by the study team

2014-09-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Radiant Research — Tucson, Arizona, United States
• Dermatology Research of Arkansas PLLC — Little Rock, Arkansas, United States
• Northwestern University — Chicago, Illinois, United States
• Radiant Research, Kansas City — Overland Park, Kansas, United States
• Mass General/ Brigham & Women's — Boston, Massachusetts, United States
• Department of Dermatology, Mayo Clinic — Rochester, Minnesota, United States
• UMDNJ-Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• New York University Medical Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Buffalo Medical Group PC — Williamsville, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Radiant Research — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Paddington Testing Co. — Philadelphia, Pennsylvania, United States
• Radiant Research Inc. — Anderson, South Carolina, United States
• Palmetto Clinical Trial Services LLC — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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