Clinical trial NCT00384098: Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Little Rock
country: United States
facility: Dermatology Research of Arkansas PLLC
state: Arkansas
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Overland Park
country: United States
facility: Radiant Research, Kansas City
state: Kansas
city: Boston
country: United States
facility: Mass General/ Brigham & Women's
state: Massachusetts
city: Rochester
country: United States
facility: Department of Dermatology, Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Williamsville
country: United States
facility: Buffalo Medical Group PC
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinatti
country: United States
facility: Radiant Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Co.
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research Inc.
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services LLC
state: South Carolina
Study officials:
affiliation: OPKO Renal
name: Joel Melnick, MD
role: STUDY_DIRECTOR
References: