Psoriasis
Conditions
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.
Interventions
OTHERNIS
This is a non-interventional study (NIS).
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* all the patients diagnosed as psoriasis by dermatologist in clinic.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
| The percentage of patients who achieved a PASI reduction of 100% (PASI 100) | 6 months and 12 months | PASI100 represents complete clearance. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactXiao-yong Man, MD
Outcome results
None listed