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

NCT01321164 | Completed Phase 3 DMC

• 1 other identifier: FPUVB 005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Mean reduction in Psoriasis Area and Severity Index (PASI)

  Baseline and 6 weeks

Secondary Outcomes (5)

• Mean cumulative FAE dose required to reach PASI 75

  6 months

• Mean reduction in Psoriasis Area and Severity Index (PASI)

  Baseline and 6 months

• Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)

  Baseline and 6 months

• Mean reduction in Dermatology Life Quality INDEX (DLQI)

  Baseline and 6 months

• Mean white blood cells (Leukocytes and Lymphocytes) count

  Baseline and 6 months

Study Arms (2)

Fumaric acid esters

ACTIVE COMPARATOR

Fumaric acid esters monotherapy

Drug: Fumaric acid esters

fumaric acid esters plus narrow band UVB

EXPERIMENTAL

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

Interventions

Full Body UV Therapy System UV 7002 plus fumaric acid esters DEVICE

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

Also known as: TL-01;, Irradiation therapy with narrow band UVB

fumaric acid esters plus narrow band UVB

Fumaric acid esters DRUG

Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months

Also known as: Fumaric acid

Fumaric acid esters

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
• Age between 18 and 80 years old

You may not qualify if:

• pregnant woman and satisfying women
• cancer, chronic infections, autoimmune diseases
• gastrointestinal illnesses
• liver diseases
• renal malfunctions

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna; Department of Dermatology

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Fumarates; fumaric acid

Intervention Hierarchy (Ancestors)

Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Adrian Tanew, Prof. Dr.

  Medical University of Vienna, Department of Dermatology, Division of General Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

AU (1)