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This research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. As patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. And the study was conducted to compare the effectiveness among different choices of medication in Chinese psoriasis patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIS | Other | This is a non-interventional study (NIS). |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who achieved a PASI reduction of 100% (PASI 100) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who achieved a PASI reduction of 100% (PASI 100) | PASI100 represents complete clearance. | 6 months and 12 months |
| The percentage of patients who achieved a PASI reduction of 75% (PASI 75) |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients diagnosed as psoriasis by dermatologist in clinic were under treatment or willing to be treated.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-yong Man, MD | Contact | 13600516219 | manxy@zju.edu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
| 6 months and 12 months |
| The percentage of patients who achieved a PASI reduction of 50% (PASI 50) | PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score. | 6 months and 12 months |
| static Physician Global Assessment (sPGA) = 0 | static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4. | 6 months and 12 months |
| static Investigator Global Assessment (sIGA) = 0 | static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4. | 6 months and 12 months |
| Body surface area (BSA) | The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient. | 6 months and 12 months |
| Dermatology Life Quality Index (DLQI) =0 | The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease. | 6 months and 12 months |
| Adverse Events (AEs) | Number of patients with adverse events | Up to 12 months |
| Visual Analog Scale (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has. | 6 months and 12 months |
| Beijing Children's Hospital Affiliated to Capital Medical University | Recruiting | Beijing | China |
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| the First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
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| the First Affiliated Hospital of Fujian Medical University | Recruiting | Fujian | China |
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| General Hospital of Lanzhou Military Region | Recruiting | Gansu | China |
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| Sun Yat-sen Memorial Hospital | Recruiting | Guangdong | China |
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| The Peoples' Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Guangxi | China |
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| the Affiliated Hospital of Guizhou Medical University | Recruiting | Guizhou | China |
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| The Fifth People's Hospital of Hainan Province | Recruiting | Hainan | China |
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| the First Hospital of Hebei Medical University | Recruiting | Hebei | China |
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| the Second Affiliated Hospital of Harbin Medical Unviersity | Recruiting | Heilongjiang | China |
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| Henan Provincial Peoples' Hospital | Recruiting | Henan | China |
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| the Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Hubei | China |
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| Xiangya Hospital, Central South University | Recruiting | Hunan | China |
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| the Second Affiliated Hospital of Nanchang University | Recruiting | Jiangxi | China |
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| Yanbian University Hospital | Recruiting | Jilin City | China |
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| Institute of Dermatology, Chinese Academy of Medical Sciences | Recruiting | Nanjing | China |
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| Xining First Hospital | Recruiting | Qinghai | China |
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| Shandong Provincial Hospital for Skin Diseases | Recruiting | Shandong | China |
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| Shanghai Dermatology Hospital | Recruiting | Shanghai | China |
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| Taiyuan Central Hospital | Enrolling by invitation | Shanxi | China |
| the Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Shanxi | China |
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| the First hospital of China Medical University | Recruiting | Shenyang | China |
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| Sichuan Provincial People's Hospital | Recruiting | Sichuan | China |
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| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Recruiting | Tianjin | China |
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| First Affiliated Hospital, School of Medicine, Shihezi University | Recruiting | Xinjiang | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | China |
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| the Second Affiliated Hospital of Kunming Medical University | Recruiting | Yunnan | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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