FVSA-PUVA
Comparison of Fumaric Acid Ester-PUVA (FAE-PUVA) Versus Acitretin-PUVA (Re-PUVA) in Pustular Palmoplantar Psoriasis,a Prospective, Randomized, Controlled, Single-blinded Study
Sponsor study identifier
interventional
20
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 17, 2008
Actual (reported)December 18, 2008
Actual (reported)October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Duration of remission
12 month
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
15.5 month
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.
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.
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.
Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology
Vienna, State of Vienna, 1180, Austria
Adrian Tanew, MD
Medical University of Vienna; University Clinic of Dermatology
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Estimated (date passed)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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 18, 2009
Record last verified: 2009-09
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Source: ClinicalTrials.gov.
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