Clinical trial NCT01443338: Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Keywords: Triptergium wilfordii
Acitretin
psoriasis vulgaris
Lead sponsor: Ministry of Health, China
Sponsor class: OTHER_GOV
First posted: 2011-09-29
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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%)
timeFrame: to 8 weeks treatment
Secondary outcomes:
measure: 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%)
timeFrame: to 8 weeks treatment
measure: 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%)
timeFrame: to 8 weeks treatment
measure: Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
timeFrame: to 8 weeks treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: