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

May 8, 2014 updated by: Adrian Tanew, Medical University of Vienna

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna; Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Adrian Tanew, Prof. Dr., Medical University of Vienna, Department of Dermatology, Division of General Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPUVB 005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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