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

  • STATUS
    Recruiting
  • End date
    Jun 27, 2023
  • participants needed
    120
  • sponsor
    Women's College Hospital
Updated on 27 April 2022
eczema
phototherapy
topical agents

Summary

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.

Details
Condition Atopic Dermatitis, Skin Diseases, Eczema
Treatment Narrowband UVB phototherapy, Broadband UVB phototherapy
Clinical Study IdentifierNCT04818138
SponsorWomen's College Hospital
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
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