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

Ministry of Health, China

Status and phase

Unknown

Phase 4

Conditions

Psoriasis Vulgaris

Treatments

Drug: Triptergium Wilfordii

Drug: Acitretin

Study type

Interventional

Funder types

Other

Identifiers

NCT01443338

CHINA201002016-2

Details and patient eligibility

About

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.

Enrollment

720 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.