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Chinese Psoriasis Real World Evidence Research

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ClinicalTrials.gov Identifier: NCT04465838
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaoyong Man, 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.

Condition or disease Intervention/treatment
Psoriasis Other: NIS

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Real World Evidence Study in Chinese Psoriasis Patients
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : July 13, 2030
Estimated Study Completion Date : July 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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.
Other: NIS
This is a non-interventional study (NIS).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [ Time Frame: 6 months and 12 months ]
    PASI100 represents complete clearance.

  2. The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [ Time Frame: 6 months and 12 months ]
    PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.

  3. The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [ Time Frame: 6 months and 12 months ]
    PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.

  4. static Physician Global Assessment (sPGA) = 0 [ Time Frame: 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.

  5. static Investigator Global Assessment (sIGA) = 0 [ Time Frame: 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.

  6. Body surface area (BSA) [ Time Frame: 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.

  7. Dermatology Life Quality Index (DLQI) =0 [ Time Frame: 6 months and 12 months ]
    The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.

  8. Adverse Events (AEs) [ Time Frame: Up to 12 months ]
    Number of patients with adverse events

  9. Visual Analog Scale (VAS) [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients diagnosed as psoriasis by dermatologist in clinic were under treatment or willing to be treated.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465838


Locations
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China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xiao-Yong Man, MD    13600516219    manxy@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Xiaoyong Man, Principal Investigator, Head of Dermatology, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04465838    
Other Study ID Numbers: 2020-354
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases