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

NCT ID: NCT01321164

Last Updated: 2014-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fumaric acid esters

Fumaric acid esters monotherapy

Group Type ACTIVE_COMPARATOR

Fumaric acid esters

Intervention Type DRUG

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

fumaric acid esters plus narrow band UVB

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

Group Type EXPERIMENTAL

Full Body UV Therapy System UV 7002 plus fumaric acid esters

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Fumaric acid esters

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

Intervention Type DRUG

Other Intervention Names

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TL-01; Irradiation therapy with narrow band UVB Fumaric acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Adrian Tanew

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Tanew, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical University of Vienna; Department of Dermatology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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FPUVB 005

Identifier Type: -

Identifier Source: org_study_id

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