Chinese Psoriasis Real World Evidence Research
- Conditions
- Psoriasis
- Interventions
- Other: NIS
- Registration Number
- NCT04465838
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- all the patients diagnosed as psoriasis by dermatologist in clinic.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psoriasis NIS 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.
- Primary Outcome Measures
Name Time Method The percentage of patients who achieved a PASI reduction of 100% (PASI 100) 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.
- Secondary Outcome Measures
Name Time Method The percentage of patients who achieved a PASI reduction of 75% (PASI 75) 6 months and 12 months PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
The percentage of patients who achieved a PASI reduction of 100% (PASI 100) 6 months and 12 months PASI100 represents complete clearance.
static Physician Global Assessment (sPGA) = 0 6 months and 12 months static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
Adverse Events (AEs) Up to 12 months Number of patients with adverse events
Visual Analog Scale (VAS) 6 months and 12 months Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has.
The percentage of patients who achieved a PASI reduction of 50% (PASI 50) 6 months and 12 months PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.
Dermatology Life Quality Index (DLQI) =0 6 months and 12 months The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.
static Investigator Global Assessment (sIGA) = 0 6 months and 12 months static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
Body surface area (BSA) 6 months and 12 months The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient.
Trial Locations
- Locations (29)
Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The Fifth People's Hospital of Hainan Province
🇨🇳Hainan, China
the First Hospital of Hebei Medical University
🇨🇳Hebei, China
the Second Affiliated Hospital of Harbin Medical Unviersity
🇨🇳Heilongjiang, China
Henan Provincial Peoples' Hospital
🇨🇳Henan, China
the Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, China
Yanbian University Hospital
🇨🇳Jilin, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, China
the Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Shanxi, China
the First hospital of China Medical University
🇨🇳Shenyang, China
First Affiliated Hospital, School of Medicine, Shihezi University
🇨🇳Xinjiang, China
the Second Affiliated Hospital of Kunming Medical University
🇨🇳Yunnan, China
The Peoples' Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Guangxi, China
the Affiliated Hospital of Guizhou Medical University
🇨🇳Guizhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Hubei, China
the First Affiliated Hospital of Fujian Medical University
🇨🇳Fujian, China
Xining First Hospital
🇨🇳Qinghai, China
Taiyuan Central Hospital
🇨🇳Shanxi, China
Shandong Provincial Hospital for Skin Diseases
🇨🇳Shandong, China
Sichuan Provincial People's Hospital
🇨🇳Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Beijing Children's Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China
the First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
General Hospital of Lanzhou Military Region
🇨🇳Gansu, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangdong, China
Xiangya Hospital, Central South University
🇨🇳Hunan, China
the Second Affiliated Hospital of Nanchang University
🇨🇳Jiangxi, China
Institute of Dermatology, Chinese Academy of Medical Sciences
🇨🇳Nanjing, China