The Effectiveness of Lower Cyclosporine Doses for Psoriasis

Psoriasis Clinical Trial

Official title:

Cyclosporine in the Pharmacotherapy of Psoriasis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00377325
• Other study ID #: R01AR050100
• Secondary ID: R01AR050100NIH-7
• Status: Withdrawn
• Phase: Phase 2
• First received: September 15, 2006
• Last updated: November 20, 2014
• Start date: June 2007
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months

Locations

Country	Name	City	State
United States	University of Rochester Department of Dermatology	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in psoriasis symptoms		Measured every 2 weeks	No