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Narrow-Band UVB-Therapy in Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
UVB phototherapy
UVB phototherapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical Centre, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1

group 2

Arm Description

Erythematogenic irradiation scheme

Suberythematogenic irradiation scheme

Outcomes

Primary Outcome Measures

clearance is defined as less than 10% affected body area with psoriasis compared with baseline

Secondary Outcome Measures

Full Information

First Posted
September 5, 2008
Last Updated
September 5, 2008
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00748020
Brief Title
Narrow-Band UVB-Therapy in Psoriasis
Official Title
Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Active Comparator
Arm Description
Erythematogenic irradiation scheme
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Suberythematogenic irradiation scheme
Intervention Type
Procedure
Intervention Name(s)
UVB phototherapy
Intervention Description
Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
Intervention Type
Procedure
Intervention Name(s)
UVB phototherapy
Intervention Description
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose
Primary Outcome Measure Information:
Title
clearance is defined as less than 10% affected body area with psoriasis compared with baseline
Time Frame
every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rianne Gerritsen, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre, Department of Dermatology
City
Nijmegen
ZIP/Postal Code
6525 GL
Country
Netherlands

12. IPD Sharing Statement

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Narrow-Band UVB-Therapy in Psoriasis

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