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NCT Number: NCT04465838

Chinese Psoriasis Real World Evidence Research

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

NIS

Other

This is a non-interventional study (NIS).

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao-yong Man, MD

CONTACT

[email protected]

13600516219

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Real World Evidence Study in Chinese Psoriasis Patients

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jul 10, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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