Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
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
1 other identifier
interventional
140
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 2, 2006
CompletedFirst Posted
Study publicly available on registry
October 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedSeptember 29, 2014
June 1, 2007
8 months
October 2, 2006
September 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Cincinnati, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joel Melnick, MD
OPKO Renal
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2006
First Posted
October 4, 2006
Study Start
September 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
September 29, 2014
Record last verified: 2007-06