Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

NCT ID: NCT00384098

Last Updated: 2014-09-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CTA018 cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OPKO Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Dermatology Research of Arkansas PLLC

Little Rock, Arkansas, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Radiant Research, Kansas City

Overland Park, Kansas, United States

Site Status

Mass General/ Brigham & Women's

Boston, Massachusetts, United States

Site Status

Department of Dermatology, Mayo Clinic

Rochester, Minnesota, United States

Site Status

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

New York University Medical Center

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Buffalo Medical Group PC

Williamsville, New York, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Radiant Research

Cincinnati, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Paddington Testing Co.

Philadelphia, Pennsylvania, United States

Site Status

Radiant Research Inc.

Anderson, South Carolina, United States

Site Status

Palmetto Clinical Trial Services LLC

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CTA018-CL-2001

Identifier Type: -

Identifier Source: org_study_id

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