The Effectiveness of Lower Cyclosporine Doses for Psoriasis

Cyclosporine in the Pharmacotherapy of Psoriasis

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.

Study Overview

• Status: Withdrawn
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Cyclosporine

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in psoriasis symptoms	Measured every 2 weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Francisco Tausk, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 15, 2006
• First Submitted That Met QC Criteria: September 15, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: R01AR050100 (U.S. NIH Grant/Contract); NIH-7R01AR050100