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

NCT04818138 | Terminated

• 1 other identifier: CACTI
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Skin Diseases; Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of patients achieving a validated Investigator Global Assessment (vIGA) score of 0 or 1 with a ≥ 2 point improvement from baseline

  Week 12

• Mean change in the Patient Oriented Eczema Measure (POEM) from baseline

  Week 12

• Mean change in the Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline

  Week 12

• Mean change in the Dermatology Life Quality Index (DLQI) from baseline

  Week 12

• Mean change in the Recap of atopic eczema (RECAP)

  Week 12

Other Outcomes (4)

• Mean change in EuroQol-5D-5L (EQ5D-5L) from baseline

  Week 12

• Mean change in body surface area (BSA) from baseline

  Week 12

• Change in the patient global assessment scale from baseline

  Week 12

Study Arms (2)

Narrowband UVB

ACTIVE COMPARATOR

Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.

Device: Narrowband UVB phototherapy

Broadband UVB

ACTIVE COMPARATOR

Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.

Device: Broadband UVB phototherapy

Interventions

Narrowband UVB phototherapy DEVICE

Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.

Also known as: NBUVB

Narrowband UVB

Broadband UVB phototherapy DEVICE

Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.

Also known as: BBUVB

Broadband UVB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• University of British Columbia: collaborator
• University of Toronto: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Aaron M Drucker

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: September 27, 2021
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)