Fumaric Acid Ester-PUVA Therapy Versus Acitretin -PUVA Therapy in Pustular Palmoplantar Psoriasis (FVSA-PUVA)
Recruitment status was Active, not recruiting
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Duration of remission [ Time Frame: 12 month ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| 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:
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:
|
|
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:
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Austria | |
| Medical University of Vienna; University Clinic of Dermatology; Division of Special and Environmental Dermatology | |
| Vienna, Austria, 1180 | |
| Principal Investigator: | Adrian Tanew, MD | Medical University of Vienna; University Clinic of Dermatology |
More Information
No publications provided
| 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 |
| Study First Received: | December 17, 2008 |
| Last Updated: | September 17, 2009 |
| Health Authority: | Austria: Ethikkommission |
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 Methoxsalen 5-methoxypsoralen Acitretin Photosensitizing Agents |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Keratolytic Agents |
ClinicalTrials.gov processed this record on June 17, 2013