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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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