Psoriasis VulgarisPhase 4NCT01443338
Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2
A Phase 4 study testing Triptergium Wilfordii and Acitretin in people with Psoriasis Vulgaris, run by Ministry of Health, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Triptergium Wilfordii and Acitretin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Lunfei Liu, Md, 86-571-87783743, liulunfei@medmail.com.cn
Jisu Chen, MD, 86-571-87783743, cgmcjs@msn.com
About this study
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
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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Triptergium Wilfordii, Acitretin
- Keywords
- Triptergium wilfordii, Acitretin, psoriasis vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptergium WilfordiiDrug
Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
AcitretinDrug
Capsule,10mg/Cap,30mg Qd,no more than 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Triptergium Wilfordii | Active comparator | a kind of traditional chinese medicine Receives: Drug: Triptergium Wilfordii |
| Acitretin | Active comparator | Not described Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 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%)
Measured: 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%)
Measured: to 8 weeks treatment
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Measured: to 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Zheng, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443338
- Sponsor's protocol ID
- CHINA201002016-2
- Status last verified
- Sep 2011
- First submitted
- 26 Sep 2011
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01443338
- Acronym / sponsor ID
- CHINA201002016-2
- Conditions
- Psoriasis Vulgaris
- Keywords
- Triptergium wilfordii, Acitretin, psoriasis vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Ministry of Health, ChinaOther government
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptergium Wilfordii | Active comparator | Drug: Triptergium Wilfordiia kind of traditional chinese medicine |
| Acitretin | Active comparator | Drug: Acitretin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptergium WilfordiiTablet,10mg/Tab,20mg Tid,No more than 8 Weeks | Drug | Triptergium Wilfordii |
| AcitretinCapsule,10mg/Cap,30mg Qd,no more than 8 weeks | Drug | Acitretin |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptergium Wilfordii and Acitretin in people with Psoriasis Vulgaris, run by Ministry of Health, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lunfei Liu, Dr (86-571-87783743, liulunfei@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.