Narrow-Band UVB-Therapy in Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00748020
First received: September 5, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Psoriasis
Procedure: UVB phototherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • clearance is defined as less than 10% affected body area with psoriasis compared with baseline [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: January 2003
Study Completion Date: January 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: group 2
Suberythematogenic irradiation scheme
Procedure: UVB phototherapy
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748020

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Department of Dermatology
Nijmegen, Netherlands, 6525 GL
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Rianne Gerritsen, MD, PhD Radboud University
  More Information

No publications provided

Responsible Party: M.J.P. Gerritsen, MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00748020     History of Changes
Other Study ID Numbers: UVB-MKL
Study First Received: September 5, 2008
Last Updated: September 5, 2008
Health Authority: The Netherlands: Radboud University Nijmegen Medical Centre, Department of Dermatology

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014