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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321164
First Posted: March 23, 2011
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adrian Tanew, Medical University of Vienna
  Purpose
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.

Condition Intervention Phase
Plaque Psoriasis Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters Drug: Fumaric acid esters Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Adrian Tanew, Medical University of Vienna:

Primary Outcome Measures:
  • Mean reduction in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures:
  • Mean cumulative FAE dose required to reach PASI 75 [ Time Frame: 6 months ]
  • Mean reduction in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and 6 months ]
  • Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI) [ Time Frame: Baseline and 6 months ]
  • Mean reduction in Dermatology Life Quality INDEX (DLQI) [ Time Frame: Baseline and 6 months ]
  • 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.


Enrollment: 30
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fumaric acid esters
Fumaric acid esters monotherapy
Drug: Fumaric acid esters
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Other Name: Fumaric acid
Experimental: fumaric acid esters plus narrow band UVB
Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB)
Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321164


Locations
Austria
Medical University of Vienna; Department of Dermatology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Adrian Tanew, Prof. Dr. Medical University of Vienna, Department of Dermatology, Division of General Dermatology
  More Information

Responsible Party: Adrian Tanew, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01321164     History of Changes
Other Study ID Numbers: FPUVB 005
First Submitted: March 22, 2011
First Posted: March 23, 2011
Last Update Posted: May 12, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases