PsoriasisPhase 4NCT02655705
Comparison Study of Psoriasis Severity Assessment Tools
A Phase 4 study testing Cyclosporine A and Methotrexate in people with Psoriasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cyclosporine A and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with chronic plaque psoriasis based on a clinical diagnosis
- Have > 5% body surface area involvement at screening
- Are a candidate for systemic therapy
- Are male or female patients 18 years or older
- Have given written informed consent approved by the Institutional Review Board
Who cannot join
- Have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- Have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline
- Have had etanercept within 4 weeks prior to baseline
- Have had adalimumab and infliximab within 8 weeks prior to baseline
- Have had ustekinumab within 16 weeks prior to baseline
- Presence of significant hepatic or renal disorders
Show all 9Show fewer
- Have uncontrolled arterial hypertension
- Are women who are lactating, breastfeeding or planning pregnancy
- Have any other condition that precludes from following and completing the protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, KS009
About this study
Official title: Comparison of the Performance of Subjective or Objective Psoriasis Severity Assessment Tools for the Assessment of the Improvement of Psoriasis After Oral Cyclosporine A or Methotrexate Treatment
This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment.
Read the detailed description
Patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine A (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). The primary outcome was to compare the difference between the conventional subjective Psoriasis Area and Severity Index (PASI) and the objective PASI by using Colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. The secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.
- Conditions
- Psoriasis
- Being tested
- Cyclosporine A, Methotrexate
- Keywords
- Cyclosporine, Methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Also called Cyclosporin, Ciclosporin, Cyclosporin A
Male 200 mg/day, Female 150 mg/day for 16 weeks
MethotrexateDrug
Also called Methotrexate tab
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Active comparator | Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks Receives: Drug: Cyclosporine A |
| Methotrexate | Active comparator | Methotrexate was started with 10 mg/week orally as a single dose, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time
PASI scores and oPASI scores are carried out on every visit. One dermatologist rates a PASI score. A oPASI score is obtained from oPASI formula using Colorimeter parameters L*, a* and b* values.
oPASI = 0.1×oPSI (head)×Area (head) + 0.3×oPSI (trunk)×Area (trunk) +0.2×oPSI (arm)×Area (arm) + 0.4×oPSI (leg)×Area (leg)
oPSI = 0.05 x L* - 2.5 x tan-1 (b*/a*) + 5
PASI range is 0 to 72 score. oPSI range is 1.073 to 10 score.
Measured: up to 16 weeks
Secondary outcomes (2)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Laboratory tests are performed at screening, 4, and 12 weeks. Patients are checked hemoglobin, hematocrit, white blood cell, platelet, aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, creatinine, c-reactive protein, and erythrocyte sedimentation. All patients are asked treatment-related adverse events on every visit.
Measured: Screening, 4, and 12 weeks
Proportion of patients achieving 75% and 90% PASI improvement on every visit
Investigators evaluate proportions of patients showing at least 75% and 90% improvement from baseline in PASI.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Woong Youn, Seoul National University Hospital
- Investigators
- Sang Woong Youn, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655705
- Sponsor's protocol ID
- oPASI1403
- Status last verified
- Apr 2016
- First submitted
- 4 Jan 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Publications
Choi JW, Kim BR, Choi CW, Youn SW. One device, one equation: the simplest way to objectively evaluate psoriasis severity. J Dermatol. 2015 Feb;42(2):154-8. doi: 10.1111/1346-8138.12727. Epub 2014 Dec 10.
PubMed 25492025Choi JW, Kwon SH, Youn JI, Youn SW. Objective measurements of erythema, elasticity and scale could overcome the inter- and intra-observer variations of subjective evaluations for psoriasis severity. Eur J Dermatol. 2013 Apr 1;23(2):224-9. doi: 10.1684/ejd.2013.1931.
PubMed 23518409
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance of Subjective or Objective Psoriasis Severity Assessment Tools for the Assessment of the Improvement of Psoriasis After Oral Cyclosporine A or Methotrexate Treatment
- ClinicalTrials.gov ID
- NCT02655705
- Acronym / sponsor ID
- oPASI1403
- Conditions
- Psoriasis
- Keywords
- Cyclosporine, Methotrexate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jan 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.
This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment.
Detailed description
Patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine A (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). The primary outcome was to compare the difference between the conventional subjective Psoriasis Area and Severity Index (PASI) and the objective PASI by using Colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. The secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Active comparator | Drug: Cyclosporine ACyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks |
| Methotrexate | Active comparator | Drug: MethotrexateMethotrexate was started with 10 mg/week orally as a single dose, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Present with chronic plaque psoriasis based on a clinical diagnosis
- Have > 5% body surface area involvement at screening
- Are a candidate for systemic therapy
- Are male or female patients 18 years or older
- Have given written informed consent approved by the Institutional Review Board
Key exclusion criteria (9 listed)
- Have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
- Have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline
- Have had etanercept within 4 weeks prior to baseline
- Have had adalimumab and infliximab within 8 weeks prior to baseline
- Have had ustekinumab within 16 weeks prior to baseline
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 |
|---|---|---|
| Cyclosporine AAlso: Cyclosporin, Ciclosporin, Cyclosporin AMale 200 mg/day, Female 150 mg/day for 16 weeks | Drug | Cyclosporine A |
| MethotrexateAlso: Methotrexate tabInitial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose | Drug | Methotrexate |
Primary outcome
Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time
Time frame: up to 16 weeks
PASI scores and oPASI scores are carried out on every visit. One dermatologist rates a PASI score. A oPASI score is obtained from oPASI formula using Colorimeter parameters L*, a* and b* values. oPASI = 0.1×oPSI (head)×Area (head) + 0.3×oPSI (trunk)×Area (trunk) +0.2×oPSI (arm)×Area (arm) + 0.4×oPSI (leg)×Area (leg) oPSI = 0.05 x L* - 2.5 x tan-1 (b*/a*) + 5 PASI range is 0 to 72 score. oPSI range is 1.073 to 10 score.
2 secondary outcomes
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: Screening, 4, and 12 weeks
Proportion of patients achieving 75% and 90% PASI improvement on every visit
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 25492025Choi JW, Kim BR, Choi CW, Youn SW. One device, one equation: the simplest way to objectively evaluate psoriasis severity. J Dermatol. 2015 Feb;42(2):154-8. doi: 10.1111/1346-8138.12727. Epub 2014 Dec 10.
- Background: PubMed 23518409Choi JW, Kwon SH, Youn JI, Youn SW. Objective measurements of erythema, elasticity and scale could overcome the inter- and intra-observer variations of subjective evaluations for psoriasis severity. Eur J Dermatol. 2013 Apr 1;23(2):224-9. doi: 10.1684/ejd.2013.1931.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
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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.
Sang Woong Youn, MD, PhD principal investigator
Seoul National University Bundang Hospital
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 Cyclosporine A and Methotrexate in people with Psoriasis, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 15 Apr 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655705, which also lists 2 linked publications.
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 15 Apr 2016.