Narrow-Band UVB-Therapy in Psoriasis

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Procedure: UVB phototherapy

• Registration Number: NCT00748020
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-05
• Study Completion: 2007-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Last Update Submitted: 2008-09-05
• Study First Posted: 2008-09-08
• Last Update Posted: 2008-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	UVB phototherapy	Erythematogenic irradiation scheme
group 2	UVB phototherapy	Suberythematogenic irradiation scheme

Primary Outcome Measures

Name	Time	Method
clearance is defined as less than 10% affected body area with psoriasis compared with baseline	every 4 weeks

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre, Department of Dermatology; 🇳🇱 Nijmegen, Netherlands