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

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ClinicalTrials.gov Identifier: NCT04818138
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborators:
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of British Columbia
University of Toronto
Information provided by (Responsible Party):
Aaron Drucker, Women's College Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Skin Diseases Eczema Device: Narrowband UVB phototherapy Device: Broadband UVB phototherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI) With a Nested BROadband vs Narrowband photoTherapy for Eczema (BRONTE) Randomized Controlled Trial
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: 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 Name: BBUVB




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


Secondary Outcome Measures :
  1. Proportion of patients achieving a validated Investigator Global Assessment (vIGA) score of 0 or 1 with a ≥ 2 point improvement from baseline [ Time Frame: Week 12 ]
    The IGA measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 4. Higher scores indicate worse disease.

  2. Mean change in the Patient Oriented Eczema Measure (POEM) from baseline [ Time Frame: Week 12 ]
    The POEM measures symptoms of atopic dermatitis. The minimum value is 0, the maximum is 28. Higher scores indicate more frequent symptoms.

  3. Mean change in the Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline [ Time Frame: Week 12 ]
    The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch.

  4. Mean change in the Dermatology Life Quality Index (DLQI) from baseline [ Time Frame: Week 12 ]
    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.

  5. Mean change in the Recap of atopic eczema (RECAP) [ Time Frame: Week 12 ]
    The RECAP measures atopic dermatitis control. The minimum value is 0, the maximum is 28. Higher scores indicate worse atopic dermatitis control.


Other Outcome Measures:
  1. Mean change in EuroQol-5D-5L (EQ5D-5L) from baseline [ Time Frame: Week 12 ]
    The EQ5D is an instrument to assess overall health state. Values are normalized to normative populations. Lower scores indicate worse overall health.

  2. Mean change in body surface area (BSA) from baseline [ Time Frame: Week 12 ]
    BSA is the percentage (0-100) of skin involved with atopic dermatitis lesions.

  3. Change in the patient global assessment scale from baseline [ Time Frame: Week 12 ]
    Patient global assessment measures the patient's perception of their overall atopic dermatitis severity (clear, almost clear, mild, moderate, severe).

  4. Withdrawal from phototherapy due to adverse events [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818138


Contacts
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Contact: Karen Lau 416-323-6400 ext 5159 karen.lau@wchospital.ca

Locations
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Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Karen Lau    416-323-6400 ext 5159    karen.lau@wchospital.ca   
Sponsors and Collaborators
Women's College Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of British Columbia
University of Toronto
Investigators
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Principal Investigator: Aaron M Drucker Women's College Hospital
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Responsible Party: Aaron Drucker, Scientist, Women's College Hospital
ClinicalTrials.gov Identifier: NCT04818138    
Other Study ID Numbers: CACTI
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases