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

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Triptergium Wilfordii; Drug: Acitretin

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Lunfei Liu, Md; Phone Number: 86-571-87783743; Email: liulunfei@medmail.com.cn
      • Contact: Jisu Chen, MD; Phone Number: 86-571-87783743; Email: cgmcjs@msn.com
      • Principal Investigator: Min Zheng, PHD&MD
      • Sub-Investigator: Lunfei Liu, MD
      • Sub-Investigator: JIsu Chen, MD
      • Sub-Investigator: Jianliang Yan, MD
      • Sub-Investigator: Jianyou Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triptergium Wilfordii; a kind of traditional chinese medicine	Drug: Triptergium Wilfordii; Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
Active Comparator: Acitretin	Drug: Acitretin; Capsule,10mg/Cap,30mg Qd,no more than 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs	to 8 weeks treatment

Collaborators and Investigators

• Sponsor: Ministry of Health, China

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: September 26, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: psoriasis vulgaris; Acitretin; Triptergium wilfordii
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: CHINA201002016-2