The Effectiveness of Lower Cyclosporine Doses for Psoriasis | NCT00377325

Studies
The Effectiveness of Lower Cyclosporine Doses for Psoriasis

NCT00377325

Sponsor

University of Rochester

Status

Withdrawn

Last Update Posted

Nov 21, 2014Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

Cyclosporine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AR050100	U.S. NIH Grant/Contract		View source
NIH-7R01AR050100

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated by the DSMB due to low recruitment

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Sep 15, 2006

First Submission Date that Met QC Criteria

Sep 15, 2006

First Posted Date

Sep 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2014

Last Update Posted Date

Nov 21, 2014Estimated

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Participants will receive full dose cyclosporin.	Drug: Cyclosporine
2	Experimental	Participants will receive active drug full dose until cleared, then one dose every 4 days.	Drug: Cyclosporine
3	Placebo Comparator	Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.	Drug: Cyclosporine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporine	Drug	4 mg/Kg/day; daily; liquid form; 6 months	1 2 3

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco Tausk, MD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Department of Dermatology		Rochester	New York	14642	United States

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds