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

Not Applicable

Recruiting

• Conditions: Eczema; Skin Diseases; Atopic Dermatitis
• Interventions: Device: Narrowband UVB phototherapy; Device: Broadband UVB phototherapy

• Registration Number: NCT04818138
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Study Start: 2021-09-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean change in the Eczema Area and Severity Index (EASI) from baseline	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

Name	Time	Method
Mean change in the Recap of atopic eczema (RECAP)	Week 12	The RECAP measures atopic dermatitis control. The minimum value is 0, the maximum is 28. Higher scores indicate worse atopic dermatitis control.
Mean change in the Patient Oriented Eczema Measure (POEM) from baseline	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 Dermatology Life Quality Index (DLQI) from baseline	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.
Proportion of patients achieving a validated Investigator Global Assessment (vIGA) score of 0 or 1 with a ≥ 2 point improvement from baseline	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 Peak Pruritus Numeric Rating Scale (PP-NRS) from baseline	Week 12	The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch.

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada