Plaque PsoriasisPhase 3NCT01321164
Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis
A Phase 3 study testing Full Body UV Therapy System UV 7002 plus fumaric acid esters and Fumaric acid esters in people with Plaque Psoriasis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Full Body UV Therapy System UV 7002 plus fumaric acid esters and Fumaric acid esters
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2011to Apr 2014
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
- Age between 18 and 80 years old
Who cannot join
- pregnant woman and satisfying women
- cancer, chronic infections, autoimmune diseases
- gastrointestinal illnesses
- liver diseases
- renal malfunctions
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna; Department of Dermatology
Vienna, 1090
About this study
Official title: Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis
The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.
- Conditions
- Plaque Psoriasis
- Being tested
- Full Body UV Therapy System UV 7002 plus fumaric acid esters, Fumaric acid esters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Body UV Therapy System UV 7002 plus fumaric acid estersDevice
Also called TL-01;, Irradiation therapy with narrow band UVB
Combination therapy of narrow band type B ultraviolet (UVB) therapy plus fumaric acid esters therapy.
Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months
Fumaric acid estersDrug
Also called Fumaric acid
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
| Study group | Role | What they receive |
|---|---|---|
| Fumaric acid esters | Active comparator | Fumaric acid esters monotherapy Receives: Drug: Fumaric acid esters |
| fumaric acid esters plus narrow band UVB | Experimental | Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB) Receives: Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in Psoriasis Area and Severity Index (PASI)
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Mean cumulative FAE dose required to reach PASI 75
Measured: 6 months
Mean reduction in Psoriasis Area and Severity Index (PASI)
Measured: Baseline and 6 months
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
Measured: Baseline and 6 months
Mean reduction in Dermatology Life Quality INDEX (DLQI)
Measured: Baseline and 6 months
Mean white blood cells (Leukocytes and Lymphocytes) count
Correlation between the mean white blood cells (Leukocytes and Lymphocytes) count and PASI reduction and between the mean white blood cells count and cumulative FAE dose.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Tanew, Medical University of Vienna
- Investigators
- Adrian Tanew, Prof. Dr., Principal investigator, Medical University of Vienna, Department of Dermatology, Division of General Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321164
- Sponsor's protocol ID
- FPUVB 005
- Status last verified
- May 2014
- First submitted
- 22 Mar 2011
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01321164
- Acronym / sponsor ID
- FPUVB 005
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Mar 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 main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fumaric acid esters | Active comparator | Drug: Fumaric acid estersFumaric acid esters monotherapy |
| fumaric acid esters plus narrow band UVB | Experimental | Device: Full Body UV Therapy System UV 7002 plus fumaric acid estersCombination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
- Age between 18 and 80 years old
Key exclusion criteria (5 listed)
- pregnant woman and satisfying women
- cancer, chronic infections, autoimmune diseases
- gastrointestinal illnesses
- liver diseases
- renal malfunctions
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 |
|---|---|---|
| Full Body UV Therapy System UV 7002 plus fumaric acid estersAlso: TL-01;, Irradiation therapy with narrow band UVBCombination therapy of narrow band type B ultraviolet (UVB) therapy plus fumaric acid esters therapy. Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months | Device | fumaric acid esters plus narrow band UVB |
| Fumaric acid estersAlso: Fumaric acidMonotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months | Drug | Fumaric acid esters |
Primary outcome
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and 6 weeks
5 secondary outcomes
Mean cumulative FAE dose required to reach PASI 75
Time frame: 6 months
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and 6 months
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
Time frame: Baseline and 6 months
Mean reduction in Dermatology Life Quality INDEX (DLQI)
Time frame: Baseline and 6 months
Mean white blood cells (Leukocytes and Lymphocytes) count
Time frame: Baseline and 6 months
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 12 May 2014.
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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.
Adrian Tanew, Prof. Dr. principal investigator
Medical University of Vienna, Department of Dermatology, Division of General Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Full Body UV Therapy System UV 7002 plus fumaric acid esters and Fumaric acid esters in people with Plaque Psoriasis, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 5 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 12 May 2014. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean reduction in Psoriasis Area and Severity Index (PASI) (time frame: Baseline and 6 weeks). 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 12 May 2014.