NCT00748020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

Enrollment Period

3.3 years

First QC Date

September 5, 2008

Last Update Submit

September 5, 2008

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

    every 4 weeks

Study Arms (2)

group 1

ACTIVE COMPARATOR

Erythematogenic irradiation scheme

Procedure: UVB phototherapy

group 2

ACTIVE COMPARATOR

Suberythematogenic irradiation scheme

Procedure: UVB phototherapy

Interventions

UVB phototherapyPROCEDURE

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

group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for UVB phototherapy
  • Older than 18 years

You may not qualify if:

  • No topical medication for 2 weeks
  • No systemic medication for 4 weeks
  • No medication (betablocker, lithium) interfering with psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, Department of Dermatology

Nijmegen, Nijmegen, 6525 GL, Netherlands

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rianne Gerritsen, MD, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

January 1, 2003

Primary Completion

May 1, 2006

Study Completion

January 1, 2007

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations

NL(1)