PsoriasisPhase 4NCT00748020
Narrow-Band UVB-Therapy in Psoriasis
A Phase 4 study testing UVB phototherapy in people with Psoriasis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- UVB phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible for UVB phototherapy
- Older than 18 years
Who cannot join
- No topical medication for 2 weeks
- No systemic medication for 4 weeks
- No medication (betablocker, lithium) interfering with psoriasis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre, Department of Dermatology
Nijmegen, Nijmegen, 6525 GL
About this study
Official title: Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- UVB phototherapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVB phototherapyProcedure or surgery
Group 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose
UVB phototherapyProcedure or surgery
Group 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Erythematogenic irradiation scheme Receives: Procedure: UVB phototherapy |
| group 2 | Active comparator | Suberythematogenic irradiation scheme Receives: Procedure: UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance is defined as less than 10% affected body area with psoriasis compared with baseline
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJan 2003
- Primary completionMay 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Rianne Gerritsen, MD, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748020
- Sponsor's protocol ID
- UVB-MKL
- Status last verified
- Sep 2008
- First submitted
- 5 Sep 2008
- Last updated
- 8 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow-Band UVB-Therapy in Psoriasis: Randomised Double-Blind Comparison of Erythematogenic and Suberythematogenic Irradiation Regimens
- ClinicalTrials.gov ID
- NCT00748020
- Acronym / sponsor ID
- UVB-MKL
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: UVB phototherapyErythematogenic irradiation scheme |
| group 2 | Active comparator | Procedure: UVB phototherapySuberythematogenic irradiation scheme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for UVB phototherapy
- Older than 18 years
Key exclusion criteria (3 listed)
- No topical medication for 2 weeks
- No systemic medication for 4 weeks
- No medication (betablocker, lithium) interfering with psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVB phototherapyGroup 1: every irradiation an increase of 40%, starting with 70% of the minimal erythema dose | Procedure or surgery | group 1 |
| UVB phototherapyGroup 2: every irradiation an increase of 20%, starting with 30% of the minimal erythema dose | Procedure or surgery | group 2 |
Primary outcome
clearance is defined as less than 10% affected body area with psoriasis compared with baseline
Time frame: every 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2008.
Related trials for Psoriasis
Active, not recruitingObservational study
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Psoriasis
Not yet recruitingPhase 1
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
Psoriasis, Arthritis, Psoriatic
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rianne Gerritsen, MD, PhD study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing UVB phototherapy in people with Psoriasis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clearance is defined as less than 10% affected body area with psoriasis compared with baseline (time frame: every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2008.