- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465838
Chinese Psoriasis Real World Evidence Research
A Real World Evidence Study in Chinese Psoriasis Patients
Study Overview
Detailed Description
Psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. The typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. In view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics.
This study is an observational, multi-centre study based on real-world evidence. Inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. There existed no exclusion criteria. Information were most collected by a phone application called "Psoriasis New World".
Primary outcome measure is the percentage of patients who achieved a PASI reduction of 100% (PASI 100). And Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. Also, static Physician Global Assessment (sPGA), static Investigator Global Assessment (sIGA), Body surface area (BSA) and Dermatology Life Quality Index (DLQI) are measured to assess the severity of psoriasis and the change of the disease condition. It is important to monitor all the Adverse Events (AEs) over the whole study. In addition, the laboratory examinations of patients such as liver function are also collected.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiao-yong Man, MD
- Phone Number: 13600516219
- Email: manxy@zju.edu.com
Study Locations
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Beijing, China
- Recruiting
- Beijing Children's hospital affiliated to capital medical university
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Contact:
- Zhe Xu
- Phone Number: 15801449886
- Email: zhexu_cmu@163.com
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Chongqing, China
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
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Contact:
- Ai-jun Chen
- Phone Number: 13062377863
- Email: 1360999716@qq.com
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Fujian, China
- Recruiting
- The First Affiliated Hospital Of Fujian Medical University
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Contact:
- Chao Ji
- Phone Number: 13075959049
- Email: surpassing_ji@aliyun.com
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Gansu, China
- Recruiting
- General Hospital of Lanzhou Military Region
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Contact:
- Chun-feng He
- Phone Number: 13919914800
- Email: derma_hcf@126.com
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Guangdong, China
- Recruiting
- Sun yat-sen memorial hospital
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Contact:
- Liang-chun Wang
- Phone Number: 13926496797
- Email: wliangch@mail.sysu.edu.cn
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Guangxi, China
- Recruiting
- The Peoples' Hospital of Guangxi Zhuang Autonomous Region
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Contact:
- Zhi Xie
- Phone Number: 15277094610
- Email: xz19723@126.com
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Guizhou, China
- Recruiting
- The Affiliated Hospital of Guizhou Medical University
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Contact:
- Hong-guang Lu
- Phone Number: 13984120866
- Email: hongguanglu@hotmail.com
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Hainan, China
- Recruiting
- The Fifth People's Hospital of Hainan Province
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Contact:
- Shi Gong
- Phone Number: 13976006125
- Email: gsxyh1218@163.com
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Hebei, China
- Recruiting
- The First Hospital of Hebei Medical University
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Contact:
- Guo-qiang Zhang
- Phone Number: 18531117085
- Email: zgq810328@sina.com
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Heilongjiang, China
- Recruiting
- the Second Affiliated Hospital of Harbin Medical Unviersity
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Contact:
- Bing-xue Bai
- Phone Number: 15114517408
- Email: bxuebdd@163.com
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Henan, China
- Recruiting
- Henan Provincial Peoples' Hospital
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Contact:
- Min Li, MD
- Phone Number: 13525585301
- Email: 623108070@qq.com
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Hohhot, China
- Recruiting
- The Affiliated Hospital of Inner Mongolia Medical University
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Contact:
- Jianwen Han
- Phone Number: 15047838652
- Email: hanjianwen1981@hotmail.com
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Hubei, China
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Juan Tao
- Phone Number: 13986278399
- Email: tjhappy@126.com
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Hunan, China
- Recruiting
- Xiangya Hospital, Central South University
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Contact:
- Juan Su
- Phone Number: 15116408921
- Email: sujuanderm@csu.edu.cn
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Jiangxi, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
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Contact:
- Ou-gen Liu
- Phone Number: 13576296646
- Email: 13576296646@163.com
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Jilin, China
- Recruiting
- Yanbian University Hospital
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Contact:
- Lian-hua Zhu
- Phone Number: 15526770355
- Email: zlh0228@sina.com
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Nanjing, China
- Recruiting
- Institute of Dermatology, Chinese Academy of Medical Sciences
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Contact:
- Yong Yang
- Phone Number: 13661267877
- Email: dryongyang@bjmu.edu.cn
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Qinghai, China
- Recruiting
- Xining First Hospital
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Contact:
- Yong-mei Huang
- Phone Number: 13997291656
- Email: mawenyu730126@163.com
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Shandong, China
- Recruiting
- Shandong Provincial Hospital for Skin Diseases
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Contact:
- Hong Liu
- Phone Number: 15866796024
- Email: hongyue2519@hotmail.com
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Shanghai, China
- Recruiting
- Shanghai Dermatology Hospital
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Contact:
- Yuling Shi, MD
- Phone Number: 13816213884
- Email: shiyuling1973@126.com
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Shanxi, China
- Enrolling by invitation
- Taiyuan Central Hospital
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Shanxi, China
- Recruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Contact:
- Song-mei Geng
- Phone Number: 13060423612
- Email: gsm312@yahoo.com
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Shenyang, China
- Recruiting
- The First Hospital of China Medical University
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Contact:
- Yan Wu
- Phone Number: 15840213656
- Email: jlwuyan@126.com
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Sichuan, China
- Recruiting
- Sichuan Provincial People's Hospital
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Contact:
- Shen Zhu
- Phone Number: 13983174426
- Email: zhshencq@163.com
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Tianjin, China
- Recruiting
- Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
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Contact:
- Xiang-jun Kong
- Phone Number: 18587535831
- Email: xiangjunkong00@gmail.com
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Xinjiang, China
- Recruiting
- First Affiliated Hospital, School of Medicine, Shihezi University
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Contact:
- Jia Zeng
- Phone Number: 13899518298
- Email: zengjia0993@sina.com
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Yinchuan, China
- Recruiting
- General Hospital of Ningxia Medical University
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Contact:
- Xin-hong Ge
- Phone Number: 13895011119
- Email: gexinhong.0101@163.com
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Yunnan, China
- Recruiting
- The Second Affiliated hospital of Kunming Medical University
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Contact:
- Yun Guo
- Phone Number: 13769111959
- Email: gunyun256318@163.com
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Contact:
- Xiao-Yong Man, MD
- Phone Number: 13600516219
- Email: manxy@zju.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- all the patients diagnosed as psoriasis by dermatologist in clinic.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Psoriasis
This is a non-interventional study (NIS).
All the patients diagnosed as psoriasis by the dermatologists in the clinic are included in this study no matter what kind of treatment they adopt.
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This is a non-interventional study (NIS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
Time Frame: 6 months
|
Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition.
The percentage of patients who achieved a PASI reduction of 100% (PASI 100) will be measured.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
Time Frame: 6 months and 12 months
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PASI100 represents complete clearance.
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6 months and 12 months
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The percentage of patients who achieved a PASI reduction of 75% (PASI 75)
Time Frame: 6 months and 12 months
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PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
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6 months and 12 months
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The percentage of patients who achieved a PASI reduction of 50% (PASI 50)
Time Frame: 6 months and 12 months
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PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.
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6 months and 12 months
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static Physician Global Assessment (sPGA) = 0
Time Frame: 6 months and 12 months
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static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
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6 months and 12 months
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static Investigator Global Assessment (sIGA) = 0
Time Frame: 6 months and 12 months
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static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
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6 months and 12 months
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Body surface area (BSA)
Time Frame: 6 months and 12 months
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The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient.
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6 months and 12 months
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Dermatology Life Quality Index (DLQI) =0
Time Frame: 6 months and 12 months
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The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.
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6 months and 12 months
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Adverse Events (AEs)
Time Frame: Up to 12 months
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Number of patients with adverse events
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Up to 12 months
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Visual Analog Scale (VAS)
Time Frame: 6 months and 12 months
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Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10.
The higher score is, the greater discomfortableness participant has.
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6 months and 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-354
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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