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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adrian Tanew, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01321164
First received: March 22, 2011
Last updated: May 8, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Medical University of Vienna:

Primary Outcome Measures:
  • Mean reduction in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean cumulative FAE dose required to reach PASI 75 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean reduction in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean reduction in Dermatology Life Quality INDEX (DLQI) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean white blood cells (Leukocytes and Lymphocytes) count [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Adrian Tanew, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01321164     History of Changes
Other Study ID Numbers: FPUVB 005
Study First Received: March 22, 2011
Last Updated: May 8, 2014
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on November 23, 2014