PsoriasisPhase 2NCT00377325
The Effectiveness of Lower Cyclosporine Doses for Psoriasis
A Phase 2 study testing Cyclosporine in people with Psoriasis, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cyclosporine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Department of Dermatology
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Cyclosporine
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
4 mg/Kg/day; daily; liquid form; 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive full dose cyclosporin. Receives: Drug: Cyclosporine |
| 2 | Experimental | Participants will receive active drug full dose until cleared, then one dose every 4 days. Receives: 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. Receives: Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in psoriasis symptoms
Measured: Measured every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionSep 2013
Why it stopped: Study terminated by the DSMB due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Francisco Tausk, University of Rochester
- Investigators
- Francisco Tausk, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377325
- Sponsor's protocol ID
- R01AR050100
- Other IDs
- R01AR050100, NIH-7R01AR050100
- Status last verified
- Nov 2014
- First submitted
- 15 Sep 2006
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclosporine in the Pharmacotherapy of Psoriasis
- ClinicalTrials.gov ID
- NCT00377325
- Acronym / sponsor ID
- R01AR050100
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by the DSMB due to low recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CyclosporineParticipants will receive full dose cyclosporin. |
| 2 | Experimental | Drug: CyclosporineParticipants will receive active drug full dose until cleared, then one dose every 4 days. |
| 3 | Placebo comparator | Drug: CyclosporineParticipants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine4 mg/Kg/day; daily; liquid form; 6 months | Drug | 1, 2, 3 |
Primary outcome
Improvement in psoriasis symptoms
Time frame: Measured every 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Tausk, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine in people with Psoriasis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in psoriasis symptoms (time frame: Measured every 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.