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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atopic Dermatitis, Skin Diseases, Eczema

Intervention / Treatment
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* Device: Narrowband UVB phototherapy
* Device: Broadband UVB phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Atopic dermatitis according to the Hanifin and Rajka criteria. Validated Investigator Global Assessment score of 3 or 4 out of 4 Eczema Area and Severity Index (EASI) score ≥7.1 Moderate to severe disease as above despite an adequate trial of topical therapy. Exclusion Criteria: Treatment with phototherapy or oral systemic immune-modulating agents (cyclosporine, methotrexate, azathioprine, mycophenolate) less than 30 days before baseline. Treatment with systemic biologic (dupilumab) or experimental therapeutic less than 90 days before baseline. Current treatment with oral or intramuscular corticosteroids within 30 days prior to baseline. Topical, intralesional or inhaled corticosteroids are allowed. Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |