What is the mechanism of action of this treatment?

The most common treatments for Atopic Dermatitis (AD) include phototherapy with Broadband Ultraviolet B (BB-UVB) and Narrowband Ultraviolet B (NB-UVB), which work by reducing inflammation and modulating the immune response. This is crucial for AD patients as it helps to control the chronic inflammation and immune dysregulation that characterize the condition. Additionally, topical corticosteroids and calcineurin inhibitors are frequently used to reduce inflammation and suppress the immune system, providing relief from symptoms and preventing flare-ups. Understanding these mechanisms helps patients appreciate the importance of these treatments in managing their condition effectively.

What side effects are associated with this type of intervention?

The most common treatments for Atopic Dermatitis, particularly phototherapy with Broadband Ultraviolet B (UVB) and Narrowband Ultraviolet B (UVB), can have side effects such as erythema (skin redness), burning, blistering, and pruritus (itching). Some patients may also experience flares in their eczema, which can lead to discontinuation of the treatment. Despite these potential side effects, Narrowband UVB is generally well tolerated and effective for many patients.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including phototherapy options like Narrowband Ultraviolet B (NB-UVB) and Broadband Ultraviolet B (BB-UVB). These therapies work by reducing inflammation and modulating the immune response in the skin. Additionally, other treatments such as topical corticosteroids, calcineurin inhibitors (e.g., tacrolimus and pimecrolimus), and systemic therapies like dupilumab have been approved. These treatments aim to manage symptoms and improve the skin barrier function in patients with atopic dermatitis.

What other types of research exist?

Promising novel alternatives to phototherapy for atopic dermatitis patients include: 1) Biologic therapies such as dupilumab, which targets the IL-4 and IL-13 pathways involved in the inflammatory response. 2) Janus kinase (JAK) inhibitors like upadacitinib and abrocitinib, which modulate immune signaling pathways. 3) Phosphodiesterase-4 (PDE-4) inhibitors such as crisaborole, which reduce inflammation. 4) Microbiome-based therapies, including topical probiotics and bacterial lysates, aimed at restoring healthy skin microbiota. These treatments offer targeted approaches to managing AD with potential for improved efficacy and safety.

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Procedure

Light Therapy for Eczema (BRONTE Trial)

N/A

Recruiting

Led By Aaron M Drucker

Research Sponsored by Women's College Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe disease as above despite an adequate trial of topical therapy.

Atopic dermatitis according to the Hanifin and Rajka criteria

Must not have

Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Summary

This trial is testing two types of light therapy to find out which is better for treating eczema. It focuses on patients who haven't had success with other treatments. The light therapy helps by reducing skin inflammation and repairing the skin barrier.

Who is the study for?

This trial is for people with moderate to severe eczema who haven't improved after using topical treatments. They must meet specific criteria for eczema severity and have not used certain medications like systemic biologics, corticosteroids, or immune-modulating agents recently.

What is being tested?

The study compares two types of UVB phototherapy: Narrowband and Broadband, to see which one better improves eczema symptoms. Participants will be randomly assigned to receive one of these treatments as part of the larger CACTI study on skin health.

What are the potential side effects?

UVB phototherapy can cause side effects such as redness, itching or burning sensations on the treated skin areas. Repeated exposure might also increase the risk of skin aging and potentially skin cancer over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition is severe despite using creams or ointments.

Select...

I have been diagnosed with atopic dermatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been in a trial for atopic dermatitis treatments in the last 90 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

+2 more

Other study objectives

Change in the patient global assessment scale from baseline

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

Mean change in body surface area (BSA) from baseline

Trial Design

2Treatment groups

Active Control

Group I: Narrowband UVBActive Control1 Intervention

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

Group II: Broadband UVBActive Control1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atopic Dermatitis (AD) include phototherapy with Broadband Ultraviolet B (BB-UVB) and Narrowband Ultraviolet B (NB-UVB), which work by reducing inflammation and modulating the immune response. This is crucial for AD patients as it helps to control the chronic inflammation and immune dysregulation that characterize the condition. Additionally, topical corticosteroids and calcineurin inhibitors are frequently used to reduce inflammation and suppress the immune system, providing relief from symptoms and preventing flare-ups. Understanding these mechanisms helps patients appreciate the importance of these treatments in managing their condition effectively.

Combined UVB and UVA phototherapy of atopic eczema.