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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

Tracking Information
First Submitted Date  ICMJE March 23, 2021
First Posted Date  ICMJE March 26, 2021
Last Update Posted Date October 12, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
Mean change in the Eczema Area and Severity Index (EASI) from baseline [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • 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 ]
  • Mean change in the Patient Oriented Eczema Measure (POEM) from baseline [ Time Frame: Week 12 ]
  • Mean change in the Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline [ Time Frame: Week 12 ]
  • Mean change in the Dermatology Life Quality Index (DLQI) from baseline [ Time Frame: Week 12 ]
  • Mean change in the Recap of atopic eczema (RECAP) [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures
 (submitted: March 25, 2021)
  • 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.
  • 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.
  • 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).
  • Withdrawal from phototherapy due to adverse events [ Time Frame: Week 12 ]
Original Other Pre-specified Outcome Measures
 (submitted: March 23, 2021)
  • Mean change in EQ5D from baseline [ Time Frame: Week 12 ]
  • Mean change in body surface area (BSA) from baseline [ Time Frame: Week 12 ]
  • Change in the patient global assessment scale from baseline [ Time Frame: Week 12 ]
  • Withdrawal from phototherapy due to adverse events [ Time Frame: Week 12 ]
 
Descriptive Information
Brief Title  ICMJE BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
Official Title  ICMJE Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI) With a Nested BROadband vs Narrowband photoTherapy for Eczema (BRONTE) Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Dermatitis
  • Skin Diseases
  • Eczema
Intervention  ICMJE
  • Device: Narrowband UVB phototherapy
    Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
    Other Name: NBUVB
  • Device: Broadband UVB phototherapy
    Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
    Other Name: BBUVB
Study Arms  ICMJE
  • Active Comparator: Narrowband UVB
    Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
    Intervention: Device: Narrowband UVB phototherapy
  • Active Comparator: Broadband UVB
    Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
    Intervention: Device: Broadband UVB phototherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Lau 416-323-6400 ext 5159 karen.lau@wchospital.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04818138
Other Study ID Numbers  ICMJE CACTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Aaron Drucker, Women's College Hospital
Study Sponsor  ICMJE Women's College Hospital
Collaborators  ICMJE
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • University of British Columbia
  • University of Toronto
Investigators  ICMJE
Principal Investigator: Aaron M Drucker Women's College Hospital
PRS Account Women's College Hospital
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP