Psoriasis VulgarisPhase 2NCT02715960
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules
A Phase 2 study testing Acitretin Capsules in people with Psoriasis Vulgaris, run by Central South University at 1 site in China.
Trial summary
In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Acitretin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed according to Classification criteria for Psoriasis vulgaris
- Patients aged 18 to 70 years (to the date of screening)
- PASI grade ≥7point
- Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.
- Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases<5 x ULN if known liver metastases, Creatinine clearance <1.5 x ULN
- Understanding the whole process of the study, voluntary participation and signed the informed consent
Who cannot join
- Pregnant women, ready to pregnant or lactating women
- Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
- Patients with chronic diarrhea, or peptic ulcer nearly 1 year
- Patients suffering from malignant tumor
- Patients suffering from acute and chronic infectious diseases
- Mental disorders, history of alcohol abuse, drug or other substance abuse
- Other cases which researchers believe that can not enroll
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Yijing He, MD, PhD, +86-1587481262, yijinghe@gmail.com
About this study
In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.
Read the detailed description
Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Acitretin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acitretin CapsulesDrug
Also called Tretinoin, Vitamine A Acid
During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | intervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece. Receives: Drug: Acitretin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate
Measured: 8 weeks after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yijing He, Central South University
- Investigators
- Xiang Chen, MD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715960
- Sponsor's protocol ID
- 2016 AW/CSU/PS
- Status last verified
- Dec 2015
- First submitted
- 17 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: data not entered
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules
- ClinicalTrials.gov ID
- NCT02715960
- Acronym / sponsor ID
- 2016 AW/CSU/PS
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Mar 2016 (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.
In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.
Detailed description
Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: Acitretin Capsulesintervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed according to Classification criteria for Psoriasis vulgaris
- Patients aged 18 to 70 years (to the date of screening)
- PASI grade ≥7point
- Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.
- Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases<5 x ULN if known liver metastases, Creatinine clearance <1.5 x ULN
Key exclusion criteria (8 listed)
- Pregnant women, ready to pregnant or lactating women
- Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
- Patients with chronic diarrhea, or peptic ulcer nearly 1 year
- Patients suffering from malignant tumor
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 |
|---|---|---|
| Acitretin CapsulesAlso: Tretinoin, Vitamine A AcidDuring The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral. | Drug | single-arm |
Primary outcome
disease control rate
Time frame: 8 weeks after the first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: Undecided. data not entered
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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.
Xiang Chen, MD principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acitretin Capsules in people with Psoriasis Vulgaris, run by Central South University 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 6 inclusion and 8 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 22 Mar 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yijing He, PhD,MD (+86-1587481262, yijinghe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate (time frame: 8 weeks after the first 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 22 Mar 2016.