Narrow-Band UVB-Therapy in Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748020
• Other study ID #: UVB-MKL
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2008
• Last updated: September 5, 2008
• Start date: January 2003
• Est. completion date: January 2007

Study information

• Verified date: September 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Radboud University Nijmegen Medical Centre, Department of Dermatology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Procedure:
• UVB phototherapy
Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
• UVB phototherapy
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, Department of Dermatology	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance is defined as less than 10% affected body area with psoriasis compared with baseline		every 4 weeks	No