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

NCT00811005 | Unknown Phase 3

• 1 other identifier: 2006-004519-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Patients will be randomized and allocated in concealed manner to one of the two treatment arms: acitretin-PUVA or FAE-PUVA.

Conditions

Pustular Palmoplantar Psoriasis

Keywords

acitretin; fumaric acid ester; pustular palmoplantar psoriasis; PUVA

Outcome Measures

Primary Outcomes (1)

• Duration of remission

  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

  15.5 month

Study Arms (2)

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.

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.

Radiation: 8-methoxypsoralen or 5- methoxypsoralen; Radiation: 8-methoxypsoralen or 5methoxypsoralen

Interventions

8-methoxypsoralen or 5- methoxypsoralen RADIATION

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.

Also known as: Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)

Acitretin-PUVA combination; Fumaric acid ester -PUVA combination

8-methoxypsoralen or 5methoxypsoralen RADIATION

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.

Also known as: Oxoralen ( 8-methoxypsoralen), Geralen( 5 methoxypsoralen)

Acitretin-PUVA combination; Fumaric acid ester -PUVA combination

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology

Vienna, Vienna, 1180, Austria

Location

MeSH Terms

Interventions

Methoxsalen; 5-Methoxypsoralen

Intervention Hierarchy (Ancestors)

Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Adrian Tanew, MD

  Medical University of Vienna; University Clinic of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2010
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

AU (1)