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

NCT ID: NCT04818138

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2025-06-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Narrowband UVB

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

Group Type: ACTIVE_COMPARATOR

Narrowband UVB phototherapy

Intervention Type: DEVICE

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

Broadband UVB

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

Group Type: ACTIVE_COMPARATOR

Broadband UVB phototherapy

Intervention Type: DEVICE

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

Interventions

Narrowband UVB phototherapy

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

Intervention Type: DEVICE

Broadband UVB phototherapy

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

Intervention Type: DEVICE

Other Intervention Names

NBUVB; BBUVB

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aaron Drucker

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron M Drucker

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CACTI

Identifier Type: -

Identifier Source: org_study_id