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Completed

NCT Number: NCT01321164

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna; Department of Dermatology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full Body UV Therapy System UV 7002 plus fumaric acid esters

Device

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

Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months

Other names: TL-01;, Irradiation therapy with narrow band UVB

Fumaric acid esters

Drug

Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months

Other names: Fumaric acid

Primary outcomes

  1. Mean reduction in Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Mean cumulative FAE dose required to reach PASI 75

    Time frame: 6 months

  2. Mean reduction in Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline and 6 months

  3. Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)

    Time frame: Baseline and 6 months

  4. Mean reduction in Dermatology Life Quality INDEX (DLQI)

    Time frame: Baseline and 6 months

  5. Mean white blood cells (Leukocytes and Lymphocytes) count

    Time frame: Baseline and 6 months

    Correlation between the mean white blood cells (Leukocytes and Lymphocytes) count and PASI reduction and between the mean white blood cells count and cumulative FAE dose.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 23, 2011
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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