Atopic DermatitisBRONTENCT04818138
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
A study testing Narrowband UVB phototherapy and Broadband UVB phototherapy in people with Atopic Dermatitis and Skin Diseases, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Skin Diseases, Eczema
- What is being tested?
- Narrowband UVB phototherapy and Broadband UVB phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2021to 5 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Atopic Dermatitis, Skin Diseases, Eczema
- Being tested
- Narrowband UVB phototherapy, Broadband UVB phototherapy
- Medical subject headings
- Dermatitis, Atopic, Skin Diseases, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVB phototherapyDevice
Also called NBUVB
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Broadband UVB phototherapyDevice
Also called BBUVB
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Narrowband UVB | Active comparator | Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. Receives: Device: Narrowband UVB phototherapy |
| Broadband UVB | Active comparator | Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols. Receives: Device: Broadband UVB phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline (95% CrI) in the Eczema Area and Severity Index (EASI)
The EASI measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 72. Higher scores indicate worse disease.
Measured: Week 12
Secondary outcomes (5)
Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline
The Investigator Global Assessment (vIGA) measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 4. Higher scores indicate worse disease.
Measured: Week 12
Absolute Change From Baseline (95% CrI) in the Patient Oriented Eczema Measure (POEM)
The POEM measures symptoms of atopic dermatitis. The minimum value is 0, the maximum is 28. Higher scores indicate more frequent symptoms.
Measured: Week 12
Absolute Change From Baseline (95% CrI) in the Peak Pruritus Numeric Rating Scale (PP-NRS)
The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch.
Measured: Week 12
Absolute Change From Baseline (95% CrI) in the Dermatology Life Quality Index (DLQI)
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.
Measured: Week 12
Absolute Change From Baseline (95% CrI) 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start27 Sep 2021
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Why it stopped: End of funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, University of British Columbia, University of Toronto
- Responsible party
- Principal investigator, Aaron Drucker, Women's College Hospital
- Investigators
- Aaron M Drucker, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818138
- Sponsor's protocol ID
- CACTI
- Acronym
- BRONTE
- Status last verified
- May 2026
- First submitted
- 23 Mar 2021
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Drucker AM, Zhong Y, Tomlinson G, Lau KPL, Walwyn C, Zhang T, Ahad T, Lui H, Jack C, Piguet V, Kalia S. Narrowband versus broadband ultraviolet B phototherapy for adults with moderate-to-severe atopic dermatitis: a randomized controlled trial. Br J Dermatol. 2026 Jul 17;195(2):232-240. doi: 10.1093/bjd/ljag161.
PubMed 42035246