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| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| University of British Columbia | OTHER |
| University of Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrowband UVB | Active Comparator | Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. |
|
| Broadband UVB | Active Comparator | Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrowband UVB phototherapy | Device | Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron M Drucker | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
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.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2026 | |
| Unrelease | May 13, 2026 | |
| Release | May 19, 2026 | |
| Reset | Jun 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 13, 2026 | |||
| May 19, 2026 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012871 | Skin Diseases |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Broadband UVB phototherapy | Device | Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. |
|
|
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 |
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 |
| Jun 16, 2026 |
| Jun 22, 2026 |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |