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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
BRONTE Trial Summary
This trial is testing two types of light therapy to see which one works better to treat eczema. The trial will also collect data on participants' eczema severity and use of treatments, as well as blood and skin samples from participants who give permission, to study the mechanisms underlying the disease.
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.Check my eligibility
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.See study design
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.
BRONTE Trial 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.
BRONTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in the Eczema Area and Severity Index (EASI) from baseline
Secondary outcome measures
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 outcome measures
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
+1 moreBRONTE 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.
Find a Location
Who is running the clinical trial?
University of British ColumbiaOTHER
1,418 Previous Clinical Trials
2,466,998 Total Patients Enrolled
Women's College HospitalLead Sponsor
101 Previous Clinical Trials
38,972 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
446 Previous Clinical Trials
159,606 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enrolled in the current clinical trial?
"Indeed, clinicaltrials.gov attests that this research effort is still ongoing and recruiting volunteers. The trial was initially posted on September 27th 2021 and the latest edits were made on March 11th 2022; 120 participants are needed from 1 facility to complete the study."
Answered by AI
Is it still feasible to join this research experiment?
"Confirmed, the clinical trial is still enrolling. The original post date was September 27th 2021 and its most recent edit occurred on March 11th 2022 according to information available at clinicaltrials.gov."
Answered by AI
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