Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.
ClinicalTrials.gov Identifier:
NCT00384098
First received: October 2, 2006
Last updated: September 26, 2014
Last verified: June 2007
  Purpose

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 Intervention Phase
Psoriasis
Drug: CTA018 cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by OPKO Health, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 140
Study Start Date: September 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384098

Locations
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.
Investigators
Study Director: Joel Melnick, MD OPKO Renal
  More Information

No publications provided

Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT00384098     History of Changes
Other Study ID Numbers: CTA018-CL-2001
Study First Received: October 2, 2006
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OPKO Health, Inc.:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 21, 2014