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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811005
First Posted: December 18, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

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.


Condition Intervention Phase
Pustular Palmoplantar Psoriasis Radiation: 8-methoxypsoralen or 5- methoxypsoralen Radiation: 8-methoxypsoralen or 5methoxypsoralen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Duration of remission [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811005


Locations
Austria
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
Vienna, Austria, 1180
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Adrian Tanew, MD Medical University of Vienna; University Clinic of Dermatology
  More Information

Responsible Party: Medical University of Vienna / MUW, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00811005     History of Changes
Other Study ID Numbers: 2006-004519-23
First Submitted: December 17, 2008
First Posted: December 18, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Medical University of Vienna:
acitretin
fumaric acid ester
pustular palmoplantar psoriasis
PUVA

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Acitretin
5-methoxypsoralen
Methoxsalen
Keratolytic Agents
Dermatologic Agents
Photosensitizing Agents