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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, China
• Treatments: Acitretin

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.