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The Effectiveness of Lower Cyclosporine Doses for Psoriasis

This study has been terminated.
(Study terminated by the DSMB due to poor recruitment)
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Francisco Tausk, University of Rochester
ClinicalTrials.gov Identifier:
NCT00377325
First received: September 15, 2006
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cyclosporine in the Pharmacotherapy of Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Improvement in psoriasis symptoms [ Time Frame: Measured every 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2007
Estimated Study Completion Date: September 2013
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Francisco Tausk, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00377325     History of Changes
Other Study ID Numbers: R01 AR050100, R01AR050100, NIH-7R01AR050100
Study First Received: September 15, 2006
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013