PsoriasisNCT04465838
Chinese Psoriasis Real World Evidence Research
An observational study of Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 29 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- NIS
- How many people
- 10,000 participants
- Where
- 29 sitesChina
- Study dates
- 8 Jul 2020to 30 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients diagnosed as psoriasis by dermatologist in clinic were under treatment or willing to be treated.
Who may be able to join
- all the patients diagnosed as psoriasis by dermatologist in clinic.
Who cannot join
- None
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 29 recruiting
- Recruiting
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing
Zhe Xu, 15801449886, zhexu_cmu@163.com
- Recruiting
the First Affiliated Hospital of Chongqing Medical University
Chongqing
Ai-jun Chen, 13062377863, 1360999716@qq.com
- Recruiting
the First Affiliated Hospital of Fujian Medical University
Fujian
Chao Ji, 13075959049, surpassing_ji@aliyun.com
- Recruiting
General Hospital of Lanzhou Military Region
Gansu
Chun-feng He, 13919914800, derma_hcf@126.com
- Recruiting
Sun Yat-sen Memorial Hospital
Guangdong
Liang-chun Wang, 13926496797, wliangch@mail.sysu.edu.cn
- Recruiting
The Peoples' Hospital of Guangxi Zhuang Autonomous Region
Guangxi
Zhi Xie, 15277094610, xz19723@126.com
- Recruiting
the Affiliated Hospital of Guizhou Medical University
Guizhou
Hong-guang Lu, 13984120866, hongguanglu@hotmail.com
- Recruiting
The Fifth People's Hospital of Hainan Province
Hainan
Shi Gong, 13976006125, gsxyh1218@163.com
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Xiao-Yong Man, MD, 13600516219, manxy@zju.edu.cn
- Recruiting
the First Hospital of Hebei Medical University
Hebei
Guo-qiang Zhang, 18531117085, zgq810328@sina.com
- Recruiting
the Second Affiliated Hospital of Harbin Medical Unviersity
Heilongjiang
Bing-xue Bai, 15114517408, bxuebdd@163.com
- Recruiting
Henan Provincial Peoples' Hospital
Henan
Min Li, MD, 13525585301, 623108070@qq.com
- Recruiting
the Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Jianwen Han, 15047838652, hanjianwen1981@hotmail.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei
Juan Tao, 13986278399, tjhappy@126.com
- Recruiting
Xiangya Hospital, Central South University
Hunan
Juan Su, 15116408921, sujuanderm@csu.edu.cn
- Recruiting
the Second Affiliated Hospital of Nanchang University
Jiangxi
Ou-gen Liu, 13576296646, 13576296646@163.com
- Recruiting
Yanbian University Hospital
Jilin City
Lian-hua Zhu, 15526770355, zlh0228@sina.com
- Recruiting
Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing
Yong Yang, 13661267877, dryongyang@bjmu.edu.cn
- Recruiting
Xining First Hospital
Qinghai
Yong-mei Huang, 13997291656, mawenyu730126@163.com
- Recruiting
Shandong Provincial Hospital for Skin Diseases
Shandong
Hong Liu, 15866796024, hongyue2519@hotmail.com
- Recruiting
Shanghai Dermatology Hospital
Shanghai
Yuling Shi, MD, 13816213884, shiyuling1973@126.com
- Enrolling by invitation
Taiyuan Central Hospital
Shanxi
- Recruiting
the Second Affiliated Hospital of Xi'an Jiaotong University
Shanxi
Song-mei Geng, 13060423612, gsm312@yahoo.com
- Recruiting
the First hospital of China Medical University
Shenyang
Yan Wu, 15840213656, jlwuyan@126.com
- Recruiting
Sichuan Provincial People's Hospital
Sichuan
Shen Zhu, 13983174426, zhshencq@163.com
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
Xiang-jun Kong, 18587535831, xiangjunkong00@gmail.com
- Recruiting
First Affiliated Hospital, School of Medicine, Shihezi University
Xinjiang
Jia Zeng, 13899518298, zengjia0993@sina.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan
Xin-hong Ge, 13895011119, gexinhong.0101@163.com
- Recruiting
the Second Affiliated Hospital of Kunming Medical University
Yunnan
Yun Guo, 13769111959, gunyun256318@163.com
About this study
Official title: A Real World Evidence Study in Chinese Psoriasis Patients
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- NIS
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISOther
This is a non-interventional study (NIS).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
PASI100 represents complete clearance.
Measured: 6 months and 12 months
The percentage of patients who achieved a PASI reduction of 75% (PASI 75)
PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months and 12 months
Adverse Events (AEs)
Number of patients with adverse events
Measured: 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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start8 Jul 2020
- Primary completion13 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyong Man, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465838
- Sponsor's protocol ID
- 2020-354
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Evidence Study in Chinese Psoriasis Patients
- ClinicalTrials.gov ID
- NCT04465838
- Acronym / sponsor ID
- 2020-354
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 13 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 10 Jul 2020 (actual)
- 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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Other: NISThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients diagnosed as psoriasis by dermatologist in clinic were under treatment or willing to be treated.
Key inclusion criteria (1 listed)
- all the patients diagnosed as psoriasis by dermatologist in clinic.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| NISThis is a non-interventional study (NIS). | Other | Psoriasis |
Primary outcome
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.
9 secondary outcomes
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
Time frame: 6 months and 12 months
The percentage of patients who achieved a PASI reduction of 75% (PASI 75)
Time frame: 6 months and 12 months
The percentage of patients who achieved a PASI reduction of 50% (PASI 50)
Time frame: 6 months and 12 months
static Physician Global Assessment (sPGA) = 0
Time frame: 6 months and 12 months
static Investigator Global Assessment (sIGA) = 0
Time frame: 6 months and 12 months
Body surface area (BSA)
Time frame: 6 months and 12 months
Dermatology Life Quality Index (DLQI) =0
Time frame: 6 months and 12 months
Adverse Events (AEs)
Time frame: Up to 12 months
Visual Analog Scale (VAS)
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriasis
Active, not recruitingObservational study
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Psoriasis
Not yet recruitingPhase 1
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
Psoriasis, Arthritis, Psoriatic
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 29 sites in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao-yong Man, MD (13600516219, manxy@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieved a PASI reduction of 100% (PASI 100) (time frame: 6 months). 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 5 Jan 2024.