Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
NCT ID: NCT00384098
Last Updated: 2014-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2006-09-30
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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CTA018 cream
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Melnick, MD
Role: STUDY_DIRECTOR
OPKO Renal
Locations
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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
Countries
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Other Identifiers
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CTA018-CL-2001
Identifier Type: -
Identifier Source: org_study_id
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