BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort (BRONTE)

Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI) With a Nested BROadband vs Narrowband photoTherapy for Eczema (BRONTE) Randomized Controlled Trial

Atopic dermatitis (eczema) is a complicated skin condition. In fact, it represents many different underlying problems. These include abnormalities in the skin barrier, the immune system and the ability to handle different bacteria. Despite many recent gains in the understanding of eczema, a lot needs to be learned. There is little evidence to select between some of the older treatments that are available now. Even the newest targeted therapy does not clear most patients' skin. In order to improve the understanding of eczema, how to treat it now, and to enable discovery of new treatments, the investigators plan to enroll patients into a large study at three centres in Canada (University of Toronto, McGill University and University of British Columbia). The study is called the Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI). In this study, the investigators will collect data on how severe participants' eczema is and what treatments they use. For participants who give permission, the investigators will collect blood and skin biopsy samples to study the mechanisms underlying their disease. The investigators will test to see which form of phototherapy (Broadband or Narrowband Ultraviolet B phototherapy) works best for eczema in a randomized clinical trial. The investigators will also use advanced imaging techniques to visualize the skin.

This trial registry entry, including the description of the treatment arms and outcomes, refer to the nested BROadband vs Narrowband photoTherapy for Eczema clinical trial.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Eczema; Atopic Dermatitis
• Intervention / Treatment: Device: Narrowband UVB phototherapy; Device: Broadband UVB phototherapy

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Lau; Phone Number: 5159 416-323-6400; Email: karen.lau@wchospital.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Recruiting
      • Women's College Hospital
      • Contact: Karen Lau; Phone Number: 5159 416-323-6400; Email: karen.lau@wchospital.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Atopic dermatitis according to the Hanifin and Rajka criteria.
2. Validated Investigator Global Assessment score of 3 or 4 out of 4
3. Eczema Area and Severity Index (EASI) score ≥7.1
4. Moderate to severe disease as above despite an adequate trial of topical therapy.

Exclusion Criteria:

1. Treatment with phototherapy or oral systemic immune-modulating agents (cyclosporine, methotrexate, azathioprine, mycophenolate) less than 30 days before baseline.
2. Treatment with systemic biologic (dupilumab) or experimental therapeutic less than 90 days before baseline.
3. Current treatment with oral or intramuscular corticosteroids within 30 days prior to baseline. Topical, intralesional or inhaled corticosteroids are allowed.
4. Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Narrowband UVB; Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.	Device: Narrowband UVB phototherapy; Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.; Other Names: NBUVB
Active Comparator: Broadband UVB; Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.	Device: Broadband UVB phototherapy; Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.; Other Names: BBUVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in the Eczema Area and Severity Index (EASI) from baseline	The EASI measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 72. Higher scores indicate worse disease.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving a validated Investigator Global Assessment (vIGA) score of 0 or 1 with a ≥ 2 point improvement from baseline	The IGA measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 4. Higher scores indicate worse disease.	Week 12
Mean change in the Patient Oriented Eczema Measure (POEM) from baseline	The POEM measures symptoms of atopic dermatitis. The minimum value is 0, the maximum is 28. Higher scores indicate more frequent symptoms.	Week 12
Mean change in the Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline	The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch.	Week 12
Mean change in the Dermatology Life Quality Index (DLQI) from baseline	The DLQI measures skin-specific quality of life. The minimum value is 0, the maximum is 30. Higher scores indicate worse impact on quality of life.	Week 12
Mean change in the Recap of atopic eczema (RECAP)	The RECAP measures atopic dermatitis control. The minimum value is 0, the maximum is 28. Higher scores indicate worse atopic dermatitis control.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in EuroQol-5D-5L (EQ5D-5L) from baseline	The EQ5D is an instrument to assess overall health state. Values are normalized to normative populations. Lower scores indicate worse overall health.	Week 12
Mean change in body surface area (BSA) from baseline	BSA is the percentage (0-100) of skin involved with atopic dermatitis lesions.	Week 12
Change in the patient global assessment scale from baseline	Patient global assessment measures the patient's perception of their overall atopic dermatitis severity (clear, almost clear, mild, moderate, severe).	Week 12
Withdrawal from phototherapy due to adverse events		Week 12

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Collaborators: University of British Columbia; McGill University Health Centre/Research Institute of the McGill University Health Centre; University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Skin Diseases; Dermatitis, Atopic
• Other Study ID Numbers: CACTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The full protocol for the CACTI study and nested BRONTE trial will be made publicly available.

The anonymized participant-level dataset and statistical code for the BRONTE trial will be made available to qualified investigators upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No