MedDataX Logo

Narrow-Band UVB-Therapy in Psoriasis

NCT ID: NCT00748020

Last Updated: 2008-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

Erythematogenic irradiation scheme

Group Type ACTIVE_COMPARATOR

UVB phototherapy

Intervention Type PROCEDURE

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

group 2

Suberythematogenic irradiation scheme

Group Type ACTIVE_COMPARATOR

UVB phototherapy

Intervention Type PROCEDURE

Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UVB phototherapy

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

Intervention Type PROCEDURE

UVB phototherapy

Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radboud University Nijmegen Medical Centre

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rianne Gerritsen, MD, PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radboud University Nijmegen Medical Centre, Department of Dermatology

Nijmegen, Nijmegen, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UVB-MKL

Identifier Type: -

Identifier Source: org_study_id