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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00384098

Recruitment Status:

Completed

Sponsor:

OPKO Health, Inc.

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There are 16 Locations for this study

See Locations Near You

Radiant Research
Tucson Arizona, 85710, United States
Dermatology Research of Arkansas PLLC
Little Rock Arkansas, 72205, United States
Northwestern University
Chicago Illinois, 60611, United States
Radiant Research, Kansas City
Overland Park Kansas, 66215, United States
Mass General/ Brigham & Women's
Boston Massachusetts, 02215, United States
Department of Dermatology, Mayo Clinic
Rochester Minnesota, 55905, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick New Jersey, 08903, United States
New York University Medical Center
New York New York, 10016, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Buffalo Medical Group PC
Williamsville New York, 14221, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Radiant Research
Cincinatti Ohio, 45249, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Paddington Testing Co.
Philadelphia Pennsylvania, 19103, United States
Radiant Research Inc.
Anderson South Carolina, 29621, United States
Palmetto Clinical Trial Services LLC
Greenville South Carolina, 29607, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT00384098

Recruitment Status:

Completed

Sponsor:


OPKO Health, Inc.

How clear is this clinincal trial information?

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