The Effectiveness of Lower Cyclosporine Doses for Psoriasis
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ClinicalTrials.gov Identifier: NCT00377325 |
Recruitment Status :
Withdrawn
(Study terminated by the DSMB due to low recruitment)
First Posted : September 18, 2006
Last Update Posted : November 21, 2014
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis | Drug: Cyclosporine | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 0 participants |
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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants will receive full dose cyclosporin.
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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.
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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.
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Drug: Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months |
- Improvement in psoriasis symptoms [ Time Frame: Measured every 2 weeks ]

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

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
United States, New York | |
University of Rochester Department of Dermatology | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Francisco Tausk, MD | University of Rochester |
Responsible Party: | Francisco Tausk, Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT00377325 |
Other Study ID Numbers: |
R01AR050100 ( U.S. NIH Grant/Contract ) R01AR050100 ( U.S. NIH Grant/Contract ) NIH-7R01AR050100 |
First Posted: | September 18, 2006 Key Record Dates |
Last Update Posted: | November 21, 2014 |
Last Verified: | November 2014 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Cyclosporine Cyclosporins 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 |