Chinese Psoriasis Real World Evidence Research

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - all the patients diagnosed as psoriasis by dermatologist in clinic.

Exclusion Criteria:

- None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04465838
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Other: - NIS

This is a non-interventional study (NIS).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000

Site Contact

Xiao-Yong Man, MD

[email protected]

13600516219

Beijing, China

Status

Recruiting

Address

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, ,

Site Contact

Zhe Xu

[email protected]

15801449886

Chongqing, China

Status

Recruiting

Address

the First Affiliated Hospital of Chongqing Medical University

Chongqing, ,

Site Contact

Ai-jun Chen

[email protected]

13062377863

Fujian, China

Status

Recruiting

Address

the First Affiliated Hospital of Fujian Medical University

Fujian, ,

Site Contact

Chao Ji

[email protected]

13075959049

Gansu, China

Status

Recruiting

Address

General Hospital of Lanzhou Military Region

Gansu, ,

Site Contact

Chun-feng He

[email protected]

13919914800

Sun Yat-sen Memorial Hospital, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen Memorial Hospital

Guangdong, ,

Site Contact

Liang-chun Wang

[email protected]

13926496797

Guangxi, China

Status

Recruiting

Address

The Peoples' Hospital of Guangxi Zhuang Autonomous Region

Guangxi, ,

Site Contact

Zhi Xie

[email protected]

15277094610

Guizhou, China

Status

Recruiting

Address

the Affiliated Hospital of Guizhou Medical University

Guizhou, ,

Site Contact

Hong-guang Lu

[email protected]

13984120866

Hainan, China

Status

Recruiting

Address

The Fifth People's Hospital of Hainan Province

Hainan, ,

Site Contact

Shi Gong

[email protected]

13976006125

Hebei, China

Status

Recruiting

Address

the First Hospital of Hebei Medical University

Hebei, ,

Site Contact

Guo-qiang Zhang

[email protected]

18531117085

Heilongjiang, China

Status

Recruiting

Address

the Second Affiliated Hospital of Harbin Medical Unviersity

Heilongjiang, ,

Site Contact

Bing-xue Bai

[email protected]

15114517408

Henan Provincial Peoples' Hospital, Henan, China

Status

Recruiting

Address

Henan Provincial Peoples' Hospital

Henan, ,

Site Contact

Min Li, MD

[email protected]

13525585301

Hohhot, China

Status

Recruiting

Address

the Affiliated Hospital of Inner Mongolia Medical University

Hohhot, ,

Site Contact

Jianwen Han

[email protected]

15047838652

Hubei, China

Status

Recruiting

Address

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, ,

Site Contact

Juan Tao

[email protected]

13986278399

Hunan, China

Status

Recruiting

Address

Xiangya Hospital, Central South University

Hunan, ,

Site Contact

Juan Su

[email protected]

15116408921

Jiangxi, China

Status

Recruiting

Address

the Second Affiliated Hospital of Nanchang University

Jiangxi, ,

Site Contact

Ou-gen Liu

[email protected]

13576296646

Yanbian University Hospital, Jilin, China

Status

Recruiting

Address

Yanbian University Hospital

Jilin, ,

Site Contact

Lian-hua Zhu

[email protected]

15526770355

Nanjing, China

Status

Recruiting

Address

Institute of Dermatology, Chinese Academy of Medical Sciences

Nanjing, ,

Site Contact

Yong Yang

[email protected]

13661267877

Xining First Hospital, Qinghai, China

Status

Recruiting

Address

Xining First Hospital

Qinghai, ,

Site Contact

Yong-mei Huang

[email protected]

13997291656

Shandong, China

Status

Recruiting

Address

Shandong Provincial Hospital for Skin Diseases

Shandong, ,

Site Contact

Hong Liu

[email protected]

15866796024

Shanghai Dermatology Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Dermatology Hospital

Shanghai, ,

Site Contact

Yuling Shi, MD

[email protected]

13816213884

Taiyuan Central Hospital, Shanxi, China

Status

Enrolling by invitation

Address

Taiyuan Central Hospital

Shanxi, ,

Shanxi, China

Status

Recruiting

Address

the Second Affiliated Hospital of Xi'an Jiaotong University

Shanxi, ,

Site Contact

Song-mei Geng

[email protected]

13060423612

Shenyang, China

Status

Recruiting

Address

the First hospital of China Medical University

Shenyang, ,

Site Contact

Yan Wu

[email protected]

15840213656

Sichuan Provincial People's Hospital, Sichuan, China

Status

Recruiting

Address

Sichuan Provincial People's Hospital

Sichuan, ,

Site Contact

Shen Zhu

[email protected]

13983174426

Tianjin, China

Status

Recruiting

Address

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, ,

Site Contact

Xiang-jun Kong

[email protected]

18587535831

Xinjiang, China

Status

Recruiting

Address

First Affiliated Hospital, School of Medicine, Shihezi University

Xinjiang, ,

Site Contact

Jia Zeng

[email protected]

13899518298

Yinchuan, China

Status

Recruiting

Address

General Hospital of Ningxia Medical University

Yinchuan, ,

Site Contact

Xin-hong Ge

[email protected]

13895011119

Yunnan, China

Status

Recruiting

Address

the Second Affiliated Hospital of Kunming Medical University

Yunnan, ,

Site Contact

Yun Guo

[email protected]

13769111959

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