moderate to severe psoriasis vulgaris
Conditions
Interventions
Tripterygium wilfordii Hook F treatment group:Take Tripterygium wilfordii Hook F 2 tablets each time, 3 times a day, and the placebo of Acitretin 3 pills once a day at noon or night with meal
Acitretin treatment group:Take Acitretin 3 pills once a day at noon or night with meal, and the placebo of Tripterygium wilfordii Hook F 2 tablets each time, 3 times a day
Combination treatment group:Take Tripterygium wilfordii Hook F 2 tablets each time, 3 times a day, and Acitretin 3 pills once a day at noon or night with meal
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males and females aged between 18 to 65 years old; 2. Chronic plaque psoriasis diagnosed for at least 6 months prior to Screening; 3. Moderate to severe psoriasis at Screening and Baseline as evidenced by PASI = 10 and BSA affected by plaque-type psoriasis of = 10%; 4. Male patients must agree to use effective methods of contraception during dosing of study drug and for 3 months after stopping study drug; 5. Female patients must agree to use effective methods of contraception during dosing of study drug and for 2 years after stopping study drug; 6. Patients who signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Erythrodermic, pustular, guttate psoriasis or psoriatic arthritis; 2. Have other dermatoses that would interfere with the evaluation of psoriasis; 3. WBC15×109/L, or Neutrophil1.5 times the upper limit of normal (ULN); 5. Positive pregnancy test; 6. Have any severe or uncontrolled systemic disease (e.g. coronary heart disease, pulmonary disease, hepatic disease, kidney disease, endocrine disease, autoimmune disease, infectious disease et al.) or have a history of malignancy; 7. Have taken anti-IL-12/IL-23 antibodies within 6 months or TNF antagonists within 3 months; 8. Have used systemic treatments (e.g. methotrexate, acitretin, cyclosporine, corticosteroids et al.) within 4 weeks; 9. Have used topical medications or phototherapy that could affect psoriasis or PASI evaluation (e.g. corticosteroids, Vitamin A/D analogs, UVB, PUVA et al.) within 2 weeks; 10. Pregnant or lactating women; 11. Have shown a previous hypersensitivity to Triptergium wilfordii Hook F or Acitretin; 12. Other conditions not suitable for participation judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients achieving a 50% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI50); | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients achieving a 75% reduction in the PASI score;proportion of patients achieving a 90% reduction in the PASI score;Dermatology Quality of Life Index;Physician's Global Assessment; | — |
Countries
China
Contacts
Public ContactHongzhong Jin
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed