Narrowband UVB phototherapy at home in Psoriasis - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Psoriasis

Intervention / Treatment

Device: narrowband UVB phototherapy at home

Detailed Description

Psoriasis is a chronic recurrent skin disorder characterised by erythematosquamous lesions (plaques). Usually the abnormal areas are few, but occasionally the disease is more generalised. Psoriasis can be treated locally by application of creams and ointments, for instance corticosteroids and vitamin D3. For most patients topical therapy will suffice. However, for some patients the area involved is such that topical application is not feasible. Or for others, the skin lesions do not respond anymore to topical treatment. In that case the dermatologist may start irradiation with ultraviolet (UV) light or prescribe systemic medication.

UVB phototherapy is a commonly used treatment for patients with psoriasis. Generally it is performed in the outpatient department of the hospital. The UVB irradiation itself will normally take only a few minutes, but to receive the irradiation patients have to travel to the outpatient department during working hours 2 or 3 times a week. In general it is a relatively time-consuming treatment.

To overcome the drawbacks of UVB treatment in the outpatient clinic, home UVB phototherapy was introduced over 25 years ago. However, the safety and effectiveness of home UVB have been debated ever since. Despite all discussion, the number of dermatologists prescribing home UVB phototherapy to their patients seems to gradually increase. We recently demonstrated that there is no sound evidence that would either support or dissuade from prescribing home UVB phototherapy. Particularly the lack of randomised research is apparent. Therefore, the objective of this study is to assess whether UVB treatment administered in the home is as equally effective as the standard outpatient UVB phototherapy. Quality of life and cost-effectiveness are also studied.

Primary Outcome:

(SA)PASI at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year) Quality of life scores (EQ-5D, SF-36, PDI) at inclusion, start of therapy, 23 (20-26) irradiations and at end of therapy.

Costs and Cost-Effectiveness will be calculated with a time-horizon of 12 months after inclusion (questionnaires were used at inclusion, start of therapy, 23 (20-26) irradiations, end of therapy, and at every 2 months after end of therapy (maximum 1 year))

Secondary Outcome:

Cumulative dosimetry (every irradiation) Total amounts of and types of side-effects (every irradiation) Concomitant use of medication (during the whole trial, data derived from patients' pharmacists)

Study Type

Interventional

Enrollment

200

Phase

Phase 4

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

Netherlands
- - Utrecht, Netherlands, 3584 CX
    - UMC Utrecht

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Guttate or plaque psoriasis, clinically eligible for narrowband UVB (TL-01) phototherapy;
Willing to undergo treatment according to randomisation.

Exclusion criteria:

No informed consent:
- age below 18 years;
- not willing to accept one of the two treatments offered;
Practical reasons:
- not able to receive one of the two treatments offered (e.g. lack of space at home / living too far from hospital etc.);
- analphabetism (unable to read the patient-information and the questionnaires, unable to provide written answers and written informed consent);
- lack of knowledge of the Dutch language;
- not in possession of a telephone.
Expected non-compliance: lack of understanding what the study / treatment is about, with its potential consequences.
Medical contra-indications:
- malignancy of the skin in the past / at present;
- known UVB-allergy or chronic polymorphic photodermatosis;
- use (at time of inclusion) of (systemic) medication with known phototoxic or photoallergic properties;
- use (at time of inclusion) of systemic antipsoriatic medication (cyclosporin, methotrexate, neotigason, fumaric acid);
- history of exposure to ionising radiation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
(SA)PASI: whole trial (9x)
Quality of life (EQ-5D, SF-36, PDI): inclusion till end of therapy (3x)
Costs & Cost-Effectiveness: during 12 months from inclusion

Secondary Outcome Measures

Outcome Measure
Dosimetry (every irradiation)
Side-effects (every irradiation)
Use medication: whole trial

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Study Chair: Vigfús Sigurdsson, MD, PhD, UMC Utrecht
Principal Investigator: Mayke BG Koek, MD, M.Sc., UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2002

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria