Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00384098
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : September 29, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CTA018 cream Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis
Study Start Date : September 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00384098

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

Responsible Party: OPKO Health, Inc. Identifier: NCT00384098     History of Changes
Other Study ID Numbers: CTA018-CL-2001
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: June 2007

Keywords provided by OPKO Health, Inc.:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases