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Light Therapy for Eczema (BRONTE Trial)
N/A
Recruiting
Led By Aaron M Drucker
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe disease as above despite an adequate trial of topical therapy.
Atopic dermatitis according to the Hanifin and Rajka criteria
Must not have
Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of light therapy to find out which is better for treating eczema. It focuses on patients who haven't had success with other treatments. The light therapy helps by reducing skin inflammation and repairing the skin barrier.
Who is the study for?
This trial is for people with moderate to severe eczema who haven't improved after using topical treatments. They must meet specific criteria for eczema severity and have not used certain medications like systemic biologics, corticosteroids, or immune-modulating agents recently.
What is being tested?
The study compares two types of UVB phototherapy: Narrowband and Broadband, to see which one better improves eczema symptoms. Participants will be randomly assigned to receive one of these treatments as part of the larger CACTI study on skin health.
What are the potential side effects?
UVB phototherapy can cause side effects such as redness, itching or burning sensations on the treated skin areas. Repeated exposure might also increase the risk of skin aging and potentially skin cancer over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is severe despite using creams or ointments.
Select...
I have been diagnosed with atopic dermatitis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been in a trial for atopic dermatitis treatments in the last 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in the Eczema Area and Severity Index (EASI) from baseline
Secondary study objectives
Mean change in the Dermatology Life Quality Index (DLQI) from baseline
Mean change in the Patient Oriented Eczema Measure (POEM) from baseline
Mean change in the Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline
+2 moreOther study objectives
Change in the patient global assessment scale from baseline
Mean change in EuroQol-5D-5L (EQ5D-5L) from baseline
Mean change in body surface area (BSA) from baseline
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Narrowband UVBActive Control1 Intervention
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Group II: Broadband UVBActive Control1 Intervention
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Atopic Dermatitis (AD) include phototherapy with Broadband Ultraviolet B (BB-UVB) and Narrowband Ultraviolet B (NB-UVB), which work by reducing inflammation and modulating the immune response. This is crucial for AD patients as it helps to control the chronic inflammation and immune dysregulation that characterize the condition.
Additionally, topical corticosteroids and calcineurin inhibitors are frequently used to reduce inflammation and suppress the immune system, providing relief from symptoms and preventing flare-ups. Understanding these mechanisms helps patients appreciate the importance of these treatments in managing their condition effectively.
Combined UVB and UVA phototherapy of atopic eczema.
Combined UVB and UVA phototherapy of atopic eczema.
Find a Location
Who is running the clinical trial?
University of British ColumbiaOTHER
1,481 Previous Clinical Trials
2,494,796 Total Patients Enrolled
1 Trials studying Eczema
40 Patients Enrolled for Eczema
Women's College HospitalLead Sponsor
106 Previous Clinical Trials
43,441 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
471 Previous Clinical Trials
166,837 Total Patients Enrolled
University of TorontoOTHER
725 Previous Clinical Trials
1,115,572 Total Patients Enrolled
Aaron M DruckerPrincipal InvestigatorWomen's College Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken biologic or experimental drugs in the last 90 days.I haven't taken immune-modulating drugs or had phototherapy in the last 30 days.My condition is severe despite using creams or ointments.Your doctor has determined that your condition is severe, scoring 3 or 4 out of 4.I have been diagnosed with atopic dermatitis.I haven't taken oral or intramuscular steroids in the last 30 days.Your eczema severity score is higher than 7.1 according to the Eczema Area and Severity Index.I have not been in a trial for atopic dermatitis treatments in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Narrowband UVB
- Group 2: Broadband UVB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.