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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321164
• Other study ID #: FPUVB 005
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2011
• Last updated: May 8, 2014
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Drug:
• Fumaric acid esters
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months

Locations

Country	Name	City	State
Austria	Medical University of Vienna; Department of Dermatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction in Psoriasis Area and Severity Index (PASI)		Baseline and 6 weeks	No
Secondary	Mean cumulative FAE dose required to reach PASI 75		6 months	No
Secondary	Mean reduction in Psoriasis Area and Severity Index (PASI)		Baseline and 6 months	No
Secondary	Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)		Baseline and 6 months	No
Secondary	Mean reduction in Dermatology Life Quality INDEX (DLQI)		Baseline and 6 months	No
Secondary	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.	Baseline and 6 months	No