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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Ministry of Health, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Min Zheng, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01443338
First received: September 26, 2011
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: Triptergium Wilfordii
Drug: Acitretin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, China:

Primary Outcome Measures:
  • 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%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]
  • 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%) [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: No ]
  • Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs [ Time Frame: to 8 weeks treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 720
Study Start Date: September 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443338

Contacts
Contact: Lunfei Liu, Dr 86-571-87783743 liulunfei@medmail.com.cn
Contact: Jisu Chen, Dr 86-571-87783743 cgmcjs@msn.com

Locations
China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Lunfei Liu, Md    86-571-87783743    liulunfei@medmail.com.cn   
Contact: Jisu Chen, MD    86-571-87783743    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         
Sponsors and Collaborators
Ministry of Health, China
  More Information

No publications provided

Responsible Party: Min Zheng, Head of dermatology, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01443338     History of Changes
Other Study ID Numbers: CHINA201002016-2
Study First Received: September 26, 2011
Last Updated: September 28, 2011
Health Authority: China: Ministry of Health

Keywords provided by Ministry of Health, China:
Triptergium wilfordii
Acitretin
psoriasis vulgaris

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014