Narrow-Band UVB-Therapy in Psoriasis

September 5, 2008 updated by: Radboud University Medical Center

Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens

Study on two different irradiation schemes in UVB phototherapy for psoriasis. Previous studies demonstrated a similar clinical effect in erythematogenic and suberythematogenic irradiation, with less complications in suberythematogenic irradiation. Most of these studies used both irradiation schemes within the same patient. UVB has a systemic effect on the body. Our hypothesis is that previous conclusions are incorrect and that the erythematogenic scheme will result in earlier clearance of the psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

109 psoriasis patients, referred for UVB phototherapy, participated in our study after given their written informed consent. After determining the minimal erythema dose (MED) patients were randomised in either group 1, erythematogenic scheme, or group 2, suberythematogenic scheme. Group 1 started with 70% of MED and every following irradiation with an increase of 40%. Group 2 started with 30% of MED and every next visit an increase of 20%. The study protocol was adjusted in case of erythema (sunburn) according to a standard erythema-phototherapy protocol, varying from skip one irradiation to lowering the percentage of increase. In case of clearance the study stopped. Clearance was defined as less than 10% of baseline body area of psoriasis.

Study Type

Interventional

Enrollment (Actual)

109

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
      • Nijmegen, Netherlands, 6525 GL
        • Radboud University Nijmegen Medical Centre, Department of Dermatology

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:

  • Eligible for UVB phototherapy
  • Older than 18 years

Exclusion Criteria:

  • No topical medication for 2 weeks
  • No systemic medication for 4 weeks
  • No medication (betablocker, lithium) interfering with psoriasis

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
Erythematogenic irradiation scheme
Procedure: UVB phototherapy
Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
Procedure: UVB phototherapy
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose
Active Comparator: group 2
Suberythematogenic irradiation scheme
Procedure: UVB phototherapy
Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
Procedure: UVB phototherapy
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clearance is defined as less than 10% affected body area with psoriasis compared with baseline
Time Frame: every 4 weeks
every 4 weeks

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Study Director: Rianne Gerritsen, MD, PhD, Radboud University Medical Center

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

January 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 8, 2008

Last Update Submitted That Met QC Criteria

September 5, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVB-MKL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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