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The Effectiveness of Lower Cyclosporine Doses for Psoriasis

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cyclosporine

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Rochester Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Participants will receive full dose cyclosporin.

Participants will receive active drug full dose until cleared, then one dose every 4 days.

Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.

Outcomes

Primary Outcome Measures

Improvement in psoriasis symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT00377325

First Posted

September 15, 2006

Last Updated

November 20, 2014

Sponsor

University of Rochester

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

1. Study Identification

Unique Protocol Identification Number

NCT00377325

Brief Title

The Effectiveness of Lower Cyclosporine Doses for Psoriasis

Official Title

Cyclosporine in the Pharmacotherapy of Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Study terminated by the DSMB due to low recruitment

Study Start Date

June 2007 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Participants will receive full dose cyclosporin.

Arm Title

Arm Type

Experimental

Arm Description

Participants will receive active drug full dose until cleared, then one dose every 4 days.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.

Intervention Type

Drug

Intervention Name(s)

Cyclosporine

Intervention Description

4 mg/Kg/day; daily; liquid form; 6 months

Primary Outcome Measure Information:

Title

Improvement in psoriasis symptoms

Time Frame

Measured every 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco Tausk, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Department of Dermatology

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

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The Effectiveness of Lower Cyclosporine Doses for Psoriasis

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