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Narrow-Band UVB-Therapy in Psoriasis

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ClinicalTrials.gov Identifier: NCT00748020
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : September 8, 2008
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Psoriasis Procedure: UVB phototherapy Phase 4

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  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens
Study Start Date : January 2003
Primary Completion Date : May 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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
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

Primary Outcome Measures :
  1. clearance is defined as less than 10% affected body area with psoriasis compared with baseline [ Time Frame: every 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748020

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

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
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: September 8, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases