- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693470
The Difference of Microparticles in Patients With Psoriasis Vulgaris Who Received Stelara(Ustekinumab)
The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic vascular diseases, including stroke, myocardial infarction, and impaired microcirculations, among which circulating microparticles play an important role. In severe psoriasis, there are increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would decrease the level of microparticles remains unknown.
Objective: The investigators will evaluate the level of microparticles among normal control, severe psoriasis before and 4 months after ustekinumab treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Shang-Hung Lin, M.D.
- Phone Number: 2424 +886-7-7317123
- Email: hongfufu@gmail.com
Study Contact Backup
- Name: Chih-Hung Lee, M.D.PhD
- Phone Number: 2424 +886-7-7317123
- Email: dermlee@gmail.com
Study Locations
-
-
-
Kaohsiung, Taiwan, 833
- Recruiting
- Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
-
Contact:
- Chih-Hung Lee, M.D., PhD
- Phone Number: 2424 +886-7-7317123
- Email: dermlee@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with severe psoriasis who receive ustekinumab treatment.
- Patients in the control group are examined thoroughly to make sure no psoriatic lesions by two dermatologists. Age, sex, lipid profiles, and blood pressure are recorded for all subjects.
Exclusion Criteria:
- The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single-arm study
50 patients with severe psoriasis who received Stelara(ustekinumab) at 0 and 1 month. The investigators check microparticles level at baseline and 4 months later. 50 patients without psoriasis: the microparticles are checked at baseline. |
50 patients with severe psoriasis received ustekinumab 45mg at 0 and 1 month.
There were 50 healthy controls.
The levels of circulating CD31 and CD41a positive microparticles are measured.
In patients with psoriasis, the investigators measure microparticles in the baseline and 4 months after ustekinumab.
For control group, the investigators measure microparticles in the baseline.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment.
Time Frame: The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab.
|
The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis
Time Frame: Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline.
|
Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chih-Hung Lee, M.D.PhD, Chang Gung memorial hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGMH-0312A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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