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Completed

NCT Number: NCT00748020

Narrow-Band UVB-Therapy in Psoriasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre, Department of Dermatology

Nijmegen, 6525 GL, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UVB phototherapy

Procedure

Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose

Primary outcomes

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

    Time frame: every 4 weeks

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Sep 8, 2008
Registry last updated
Sep 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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