Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters; Drug: Fumaric acid esters

Study type: Interventional

Funder types: Other

Identifiers

NCT01321164

FPUVB 005

Details and patient eligibility

About

The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
• Age between 18 and 80 years old

Exclusion criteria

• pregnant woman and satisfying women
• cancer, chronic infections, autoimmune diseases
• gastrointestinal illnesses
• liver diseases
• renal malfunctions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Fumaric acid esters

Active Comparator group

Description:

Fumaric acid esters monotherapy

Treatment:

Drug: Fumaric acid esters

fumaric acid esters plus narrow band UVB

Experimental group

Description:

Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB)

Treatment:

Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters