NCT01443338

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

September 26, 2011

Last Update Submit

September 28, 2011

Conditions

Psoriasis Vulgaris

Keywords

Triptergium wilfordiiAcitretinpsoriasis vulgaris

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Triptergium Wilfordii

ACTIVE COMPARATOR

a kind of traditional chinese medicine

Drug: Triptergium Wilfordii

Acitretin

ACTIVE COMPARATOR
Drug: Acitretin

Interventions

Triptergium WilfordiiDRUG

Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks

Triptergium Wilfordii
AcitretinDRUG

Capsule,10mg/Cap,30mg Qd,no more than 8 weeks

Acitretin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Acitretin

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Central Study Contacts

Lunfei Liu, Dr

CONTACT

86-571-87783743liulunfei@medmail.com.cn

Jisu Chen, Dr

CONTACT

86-571-87783743cgmcjs@msn.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of dermatology

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 29, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

CN(1)