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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01443338
• Other study ID #: CHINA201002016-2
• Status: Recruiting
• Phase: Phase 4
• First received: September 26, 2011
• Last updated: September 28, 2011
• Start date: September 2011

Study information

• Verified date: September 2011
• Source: Ministry of Health, China
• Contact: Lunfei Liu, Dr
• Phone: 86-571-87783743
• Email: liulunfei[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Triptergium Wilfordii
Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
• Acitretin
Capsule,10mg/Cap,30mg Qd,no more than 8 weeks

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

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