Psoriasis Vulgaris Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 720 |
Est. completion date | |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Ministry of Health, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs | to 8 weeks treatment | Yes |
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