Pustular Palmoplantar PsoriasisPhase 3FVSA-PUVANCT00811005
Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis
A Phase 3 study testing 8-methoxypsoralen or 5- methoxypsoralen and 8-methoxypsoralen or 5methoxypsoralen in people with Pustular Palmoplantar Psoriasis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pustular Palmoplantar Psoriasis
- What is being tested?
- 8-methoxypsoralen or 5- methoxypsoralen and 8-methoxypsoralen or 5methoxypsoralen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2008to Oct 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pustular palmoplantar psoriasis
- Patients older than 18 years
Who cannot join
- Pregnant and lactating women
- Uncontrolled hyperlipidemia
- Patients with severely impaired hepatic function
- Patients with severely impaired renal function
- Immunosuppression.
- Abnormal UVA sensitivity
Show all 9Show fewer
- Intake of photosensitizing drugs
- Oral antipsoriatic therapy within the last 4 weeks
- Topical antipsoriatic therapy within the last 2 weeks
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
Vienna, State of Vienna, 1180
About this study
Official title: Comparison of Fumaric Acid Ester-PUVA (FAE-PUVA) Versus Acitretin-PUVA (Re-PUVA) in Pustular Palmoplantar Psoriasis,a Prospective, Randomized, Controlled, Single-blinded Study
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis.
Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.
Read the detailed description
Acitretin-PUVA treatment schedule:
Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in a dose of 1mg /kg daily two weeks prior to additional PUVA treatment.
Acitretin-PUVA combination: PUVA treatment (see below) will be applied thrice weekly in addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
Acitretin maintenance therapy: After (near) complete clearance patients will be continued on a maintenance dose of 0.5 mg/kg acitretin over 6 months or until significant relapse. Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of the baseline score) will be followed up until significant relapse or over a maximum period of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
FAE-PUVA treatment schedule:
FAE monotherapy: Patients randomized to this group will receive FAE in weekly incremental doses (initial daily dose: 30 mg dimethylfumarate (DMF), highest daily dose: 720 mg DMF) starting two weeks prior to additional PUVA treatment.
FAE-PUVA combination: PUVA treatment will be applied thrice weekly in addition to FAE until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
FAE maintenance therapy: After (near) complete clearance FAE will be reduced weekly by 120 mg DMF to a daily maintenance dose of 360 mg DMF which will be administered for a maximum period of 6 months or until significant relapse. Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of the baseline score) will be followed up until significant relapse or over a maximum period of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet.
Primary outcome measure:
Duration of remission
Secondary outcome measures:
Percentage of patients achieving remission Number of PUVA exposures required for inducing remission Total UVA exposure dose required for inducing remission Frequency and quality of adverse reactions
Assessment of clinical response:
A modified local PASI (psoriasis area and severity index) score adapted for the evaluation of the hands and feet will be performed by a blinded investigator at baseline and the onset of PUVA treatment, in biweekly intervals during the course of PUVA treatment, in monthly intervals after discontinuation of PUVA and in bimonthly intervals during a 1-year follow-up period. The study will be terminated in case of a significant relapse which is defined by a PASI score of ≥50 % of the baseline score.
Monitoring:
Prior to the study the blood chemistry, complete blood cell count including differential, urine analysis, TSH, TPO- and TG autoantibodies, a pregnancy tests (in women of childbearing potential) and an ophthalmological examination will be performed. During the study the complete blood cell count, blood chemistry, urine analysis and pregnancy test (in women of childbearing potential) will be reexamined monthly.
- Conditions
- Pustular Palmoplantar Psoriasis
- Being tested
- 8-methoxypsoralen or 5- methoxypsoralen, 8-methoxypsoralen or 5methoxypsoralen
- Keywords
- acitretin, fumaric acid ester, pustular palmoplantar psoriasis, PUVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-methoxypsoralen or 5- methoxypsoralenRadiation
Also called Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet.
8-methoxypsoralen or 5methoxypsoralenRadiation
Also called Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet.
| Study group | Role | What they receive |
|---|---|---|
| Acitretin-PUVA combination | Active comparator | Acitretin-PUVA combination:
Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in a dose of 1mg /kg daily two weeks prior to additional PUVA treatment.
PUVA treatment (see below) will be applied thrice weekly in addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. Receives: Radiation: 8-methoxypsoralen or 5- methoxypsoralen; Radiation: 8-methoxypsoralen or 5methoxypsoralen |
| Fumaric acid ester -PUVA combination | Experimental | FAE monotherapy:
Patients randomized to this group will receive FAE in weekly incremental doses (initial daily dose: 30 mg dimethylfumarate (DMF), highest daily dose: 720 mg DMF) starting two weeks prior to additional PUVA treatment.
FAE-PUVA combination:
PUVA treatment will be applied thrice weekly in addition to FAE until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. Receives: Radiation: 8-methoxypsoralen or 5- methoxypsoralen; Radiation: 8-methoxypsoralen or 5methoxypsoralen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of remission
Measured: 12 month
Secondary outcomes (1)
Secondary outcome measures: Percentage of patients achieving remission Number of PUVA exposures required for inducing remission Total UVA exposure dose required for inducing remission Frequency and quality of adverse reactions
Measured: 15.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pustular Palmoplantar 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Adrian Tanew, MD, Principal investigator, Medical University of Vienna; University Clinic of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811005
- Sponsor's protocol ID
- 2006-004519-23
- Acronym
- FVSA-PUVA
- Status last verified
- Sep 2009
- First submitted
- 17 Dec 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fumaric Acid Ester-PUVA (FAE-PUVA) Versus Acitretin-PUVA (Re-PUVA) in Pustular Palmoplantar Psoriasis,a Prospective, Randomized, Controlled, Single-blinded Study
- ClinicalTrials.gov ID
- NCT00811005
- Acronym / sponsor ID
- FVSA-PUVA / 2006-004519-23
- Conditions
- Pustular Palmoplantar Psoriasis
- Keywords
- acitretin, fumaric acid ester, pustular palmoplantar psoriasis, PUVA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 18 Dec 2008 (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 prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of oral photochemotherapy (PUVA) combined with acitretin versus oral PUVA combined with systemic fumaric acid esters (FAE) in patients with pustular palmoplantar psoriasis.
Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.
Detailed description
Acitretin-PUVA treatment schedule:
Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in a dose of 1mg /kg daily two weeks prior to additional PUVA treatment.
Acitretin-PUVA combination: PUVA treatment (see below) will be applied thrice weekly in addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
Acitretin maintenance therapy: After (near) complete clearance patients will be continued on a maintenance dose of 0.5 mg/kg acitretin over 6 months or until significant relapse. Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of the baseline score) will be followed up until significant relapse or over a maximum period of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
FAE-PUVA treatment schedule:
FAE monotherapy: Patients randomized to this group will receive FAE in weekly incremental doses (initial daily dose: 30 mg dimethylfumarate (DMF), highest daily dose: 720 mg DMF) starting two weeks prior to additional PUVA treatment.
FAE-PUVA combination: PUVA treatment will be applied thrice weekly in addition to FAE until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%.
FAE maintenance therapy: After (near) complete clearance FAE will be reduced weekly by 120 mg DMF to a daily maintenance dose of 360 mg DMF which will be administered for a maximum period of 6 months or until significant relapse. Significant relapse is defined by a worsening of the clinical score to ≥50 % of the baseline score.
Follow-up period: Patients who are still significantly improved (clinical score of <50% of the baseline score) will be followed up until significant relapse or over a maximum period of 12 months.
Besides emollients no additional specific treatments will be allowed during the study.
PUVA treatment:
Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation.
Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet.
Primary outcome measure:
Duration of remission
Secondary outcome measures:
Percentage of patients achieving remission Number of PUVA exposures required for inducing remission Total UVA exposure dose required for inducing remission Frequency and quality of adverse reactions
Assessment of clinical response:
A modified local PASI (psoriasis area and severity index) score adapted for the evaluation of the hands and feet will be performed by a blinded investigator at baseline and the onset of PUVA treatment, in biweekly intervals during the course of PUVA treatment, in monthly intervals after discontinuation of PUVA and in bimonthly intervals during a 1-year follow-up period. The study will be terminated in case of a significant relapse which is defined by a PASI score of ≥50 % of the baseline score.
Monitoring:
Prior to the study the blood chemistry, complete blood cell count including differential, urine analysis, TSH, TPO- and TG autoantibodies, a pregnancy tests (in women of childbearing potential) and an ophthalmological examination will be performed. During the study the complete blood cell count, blood chemistry, urine analysis and pregnancy test (in women of childbearing potential) will be reexamined monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acitretin-PUVA combination | Active comparator | Radiation: 8-methoxypsoralen or 5- methoxypsoralen, Radiation: 8-methoxypsoralen or 5methoxypsoralenAcitretin-PUVA combination: Acitretin monotherapy: Patients randomized to the acitretin group will receive acitretin in a dose of 1mg /kg daily two weeks prior to additional PUVA treatment. PUVA treatment (see below) will be applied thrice weekly in addition to acitretin until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%. PUVA treatment: Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. |
| Fumaric acid ester -PUVA combination | Experimental | Radiation: 8-methoxypsoralen or 5- methoxypsoralen, Radiation: 8-methoxypsoralen or 5methoxypsoralenFAE monotherapy: Patients randomized to this group will receive FAE in weekly incremental doses (initial daily dose: 30 mg dimethylfumarate (DMF), highest daily dose: 720 mg DMF) starting two weeks prior to additional PUVA treatment. FAE-PUVA combination: PUVA treatment will be applied thrice weekly in addition to FAE until (near) complete clearance or over a maximum period of 12 weeks. (Near) complete clearance is defined by improvement of the clinical baseline score (see below) by ≥90%. PUVA treatment: Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pustular palmoplantar psoriasis
- Patients older than 18 years
Key exclusion criteria (9 listed)
- Pregnant and lactating women
- Uncontrolled hyperlipidemia
- Patients with severely impaired hepatic function
- Patients with severely impaired renal function
- Immunosuppression.
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 |
|---|---|---|
| 8-methoxypsoralen or 5- methoxypsoralenAlso: Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet. | Radiation | Acitretin-PUVA combination, Fumaric acid ester -PUVA combination |
| 8-methoxypsoralen or 5methoxypsoralenAlso: Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)PUVA treatment: Intake of 8-methoxypsoralen in a dose of 0.6 mg/kg 1 hour before UVA irradiation or, in case of 8-methoxypsoralen intolerance, 5-methoxypsoralen in a dose of 1.2 mg/kg 2 hours before UVA irradiation. Start of PUVA 2 weeks after initiation of acitretin or FAE treatment. Irradiation will be given three times per week over a maximum period of 12 weeks (36 exposures). PUVA exposure will be limited to the hands and feet. | Radiation | Acitretin-PUVA combination, Fumaric acid ester -PUVA combination |
Primary outcome
Duration of remission
Time frame: 12 month
1 secondary outcome
Secondary outcome measures: Percentage of patients achieving remission Number of PUVA exposures required for inducing remission Total UVA exposure dose required for inducing remission Frequency and quality of adverse reactions
Time frame: 15.5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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, MD principal investigator
Medical University of Vienna; University Clinic of 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 8-methoxypsoralen or 5- methoxypsoralen and 8-methoxypsoralen or 5methoxypsoralen in people with Pustular Palmoplantar 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 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: status not confirmed, as of the sponsor's last update on 18 Sep 2009. 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?
Results are not available in the source record.
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?
Duration of remission (time frame: 12 month). 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 18 Sep 2009.