Atopic Dermatitis Clinical Trial
— BRONTEOfficial title:
Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI) With a Nested BROadband vs Narrowband photoTherapy for Eczema (BRONTE) Randomized Controlled Trial
NCT number | NCT04818138 |
Other study ID # | CACTI |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 27, 2021 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Women's College Hospital | McGill University Health Centre/Research Institute of the McGill University Health Centre, University of British Columbia, University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Mean change in body surface area (BSA) from baseline | BSA is the percentage (0-100) of skin involved with atopic dermatitis lesions. | Week 12 | |
Other | 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 | |
Other | Withdrawal from phototherapy due to adverse events | Week 12 | ||
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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