Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.

Official Title
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A Phase4,Multicenter, Randomized,Double-blind,Double Dummy, Parallel Controlled Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Treatment of Chinese Patients With Moderate to Severe Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Triptergium Wilfordii
* Drug: Acitretin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults of both sexes, between the age 18 and 75 years. Have a diagnosis of psoriasis vulgaris,PASI score of 7 or greater. Capable of giving informed consent and the consent must be obtained prior to any study related procedures. Exclusion Criteria: Currently have erythrodermic,guttate or pustular psoriasis. Have any active dermatoses which may affect disease assessment of psoriasis. Have used any investigational drug,any biologic or any systemic immunosuppressants within the previous 1 month.. Have used topical medications/treatments that could affect psoriasis or PASI evaluation (eg, corticosteroids, tar, phototherapy et al.) within 2 weeks. Have any acute or chronic or recurrent infectious disease,which was difficult to control. Have the history of HBV or HCV infection,or HIV antibody test positive. AST, ALT or blood fat levels must be within 1.5 times the ULN range for the laboratory conducting the test. Are pregnant, nursing, or planning pregnancy in the coming two years(both men and women) while enrolled in the study. Have any severe systemic disease or have a history of malignancy. Have shown a previous hypersensitivity to Triptergium wilfordii or Acitretin. Have any other condition not suitable to join in trial,which are judged by investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triptergium Wilfordii<br>a kind of traditional chinese medicine | Drug: Triptergium Wilfordii<br>* Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks<br>|
| Active Comparator: Acitretin<br> | Drug: Acitretin<br>* Capsule,10mg/Cap,30mg Qd,no more than 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plaque psoriasis as assessed by PASI(psoriasis area and severity index) response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%) |  | to 8 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plaque psoriasis as assessed by PASI response or PASI 50 (a patient that has an improvement from baseline PASI of at least 50%) |  | to 8 weeks treatment | 
| Change from baseline in plaque psoriasis as assessed by PASI response or PASI 90 (a patient that has an improvement from baseline PASI of at least 90%) |  | to 8 weeks treatment | 
| Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs |  | to 8 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triptergium wilfordii, Acitretin, psoriasis vulgaris