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

Primary Purpose

Psoriasis Vulgaris

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Triptergium Wilfordii

Acitretin

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Triptergium wilfordii, Acitretin, psoriasis vulgaris

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Triptergium Wilfordii

Acitretin

Arm Description

a kind of traditional chinese medicine

Outcomes

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%)

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%)

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%)

Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs

Full Information

NCT ID

NCT01443338

First Posted

September 26, 2011

Last Updated

September 28, 2011

Sponsor

Ministry of Health, China

1. Study Identification

Unique Protocol Identification Number

NCT01443338

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ministry of Health, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

Keywords

Triptergium wilfordii, Acitretin, psoriasis vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Triptergium Wilfordii

Arm Type

Active Comparator

Arm Description

a kind of traditional chinese medicine

Arm Title

Acitretin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Triptergium Wilfordii

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Acitretin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lunfei Liu, Dr

Phone

86-571-87783743

liulunfei@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jisu Chen, Dr

Phone

86-571-87783743

cgmcjs@msn.com

Facility Information:

Facility Name

Second Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact: