search
Back to results

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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Full Body UV Therapy System UV 7002 plus fumaric acid esters
Fumaric acid esters
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Vienna; Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fumaric acid esters

fumaric acid esters plus narrow band UVB

Arm Description

Fumaric acid esters monotherapy

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

Outcomes

Primary Outcome Measures

Mean reduction in Psoriasis Area and Severity Index (PASI)

Secondary Outcome Measures

Mean cumulative FAE dose required to reach PASI 75
Mean reduction in Psoriasis Area and Severity Index (PASI)
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
Mean reduction in Dermatology Life Quality INDEX (DLQI)
Mean white blood cells (Leukocytes and Lymphocytes) count
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.

Full Information

First Posted
March 22, 2011
Last Updated
May 8, 2014
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT01321164
Brief Title
Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis
Official Title
Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fumaric acid esters
Arm Type
Active Comparator
Arm Description
Fumaric acid esters monotherapy
Arm Title
fumaric acid esters plus narrow band UVB
Arm Type
Experimental
Arm Description
Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB)
Intervention Type
Device
Intervention Name(s)
Full Body UV Therapy System UV 7002 plus fumaric acid esters
Other Intervention Name(s)
TL-01;, Irradiation therapy with narrow band UVB
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fumaric acid esters
Other Intervention Name(s)
Fumaric acid
Intervention Description
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Primary Outcome Measure Information:
Title
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Mean cumulative FAE dose required to reach PASI 75
Time Frame
6 months
Title
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time Frame
Baseline and 6 months
Title
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
Time Frame
Baseline and 6 months
Title
Mean reduction in Dermatology Life Quality INDEX (DLQI)
Time Frame
Baseline and 6 months
Title
Mean white blood cells (Leukocytes and Lymphocytes) count
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Tanew, Prof. Dr.
Organizational Affiliation
Medical University of Vienna, Department of Dermatology, Division of General Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna; Department of Dermatology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs