Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis (FVSA-PUVA)

September 17, 2009 updated by: Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1180
        • Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with pustular palmoplantar psoriasis
  • Patients older than 18 years

Exclusion Criteria:

  • Pregnant and lactating women
  • Uncontrolled hyperlipidemia
  • Patients with severely impaired hepatic function
  • Patients with severely impaired renal function
  • Immunosuppression.
  • Abnormal UVA sensitivity
  • Intake of photosensitizing drugs
  • Oral antipsoriatic therapy within the last 4 weeks
  • Topical antipsoriatic therapy within the last 2 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acitretin-PUVA combination

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.
Radiation: 8-methoxypsoralen or 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.

Other Names:
  • Oxoralen ( 8-methoxypsoralen)
  • Geralen( 5 methoxypsoralen)
Radiation: 8-methoxypsoralen or 5methoxypsoralen

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.

Other Names:
  • Oxoralen ( 8-methoxypsoralen)
  • Geralen( 5 methoxypsoralen)
Experimental: Fumaric acid ester -PUVA combination

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.
Radiation: 8-methoxypsoralen or 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.

Other Names:
  • Oxoralen ( 8-methoxypsoralen)
  • Geralen( 5 methoxypsoralen)
Radiation: 8-methoxypsoralen or 5methoxypsoralen

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.

Other Names:
  • Oxoralen ( 8-methoxypsoralen)
  • Geralen( 5 methoxypsoralen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of remission
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
15.5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Adrian Tanew, MD, Medical University of Vienna; University Clinic of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-004519-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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