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The Effectiveness of Lower Cyclosporine Doses for Psoriasis

This study has been withdrawn prior to enrollment.
(Study terminated by the DSMB due to low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377325
First Posted: September 18, 2006
Last Update Posted: November 21, 2014
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.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Francisco Tausk, University of Rochester
  Purpose
This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with a standard cyclosporine dose regimen when treating individuals with moderate to severe psoriasis.

Condition Intervention Phase
Psoriasis Drug: Cyclosporine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cyclosporine in the Pharmacotherapy of Psoriasis

Resource links provided by NLM:


Further study details as provided by Francisco Tausk, University of Rochester:

Primary Outcome Measures:
  • Improvement in psoriasis symptoms [ Time Frame: Measured every 2 weeks ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive full dose cyclosporin.
Drug: Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
Experimental: 2
Participants will receive active drug full dose until cleared, then one dose every 4 days.
Drug: Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
Placebo Comparator: 3
Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.
Drug: Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months

Detailed Description:

Psoriasis is a chronic inflammatory skin disease. It is believed to be caused by an overactive immune system that speeds the growth of skin cells. This abnormal skin growth results in patches of inflamed skin, which can itch, crack, and bleed. Cyclosporine is an immunosuppressant drug that is used in more severe cases of psoriasis to slow down the growth of skin cells. However, cyclosporine use is associated with several side effects, including kidney damage, high blood pressure, and skin sensitivity. This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with the standard administration of cyclosporine.

Participants in this study will receive treatment with cyclosporine for up to 30 weeks. Study visits will occur every 2 weeks and will include a physical exam, a psoriasis symptom evaluation, blood collection, and various questionnaires on quality-of-life issues. Participants will be followed for 2 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Good health
  • Exception that has been resistant to psoralen and ultraviolet A radiation (PUVA), methotrexate, and retinoids
  • Moderate to severe, stable plaque psoriasis
  • Normal organ and marrow function
  • HIV uninfected

Exclusion Criteria:

  • Topical therapy within 4 weeks of study entry
  • Use of systemic, intralesional, or phototherapy within 1 year of study entry
  • Use of cyclosporine in the past or use of other immunosuppressive medication within 6 months of study entry
  • Inability to be followed or monitored regularly on a weekly basis
  • Poorly controlled hypertension
  • Severe infection, internal malignancy, immunodeficiency, gout, or liver disease
  • Received more than 1,000 treatments of ultraviolet A (UVA)
  • History of allergic reaction attributed to compounds of similar chemical or biological composition to cyclosporine
  • Uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit study participation
  • Women of childbearing potential and men unwilling to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study
  • Pregnant
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00377325


Locations
United States, New York
University of Rochester Department of Dermatology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Francisco Tausk, MD University of Rochester
  More Information

Responsible Party: Francisco Tausk, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00377325     History of Changes
Other Study ID Numbers: R01AR050100 ( U.S. NIH Grant/Contract )
NIH-7R01AR050100
First Submitted: September 15, 2006
First Posted: September 18, 2006
Last Update Posted: November 21, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors