Light Therapy for Eczema

(BRONTE Trial)

Overseen By Karen Lau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Women's College Hospital

Must not be taking: Phototherapy, Systemic biologics, Corticosteroids

Disqualifiers: Other trials, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether Broadband or Narrowband UVB light therapy is more effective for treating eczema, a skin condition that causes redness and itching. Researchers will collect data on the severity of participants' eczema, their treatments, and will analyze blood and skin samples to gain a better understanding of the disease. Individuals with moderate to severe eczema, who have not responded to creams or ointments and have not recently received light therapy or certain medications, may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance eczema treatments for all.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. If you're using phototherapy, oral immune-modulating drugs, or systemic biologics, you must stop them 30 to 90 days before starting. However, topical, intralesional, or inhaled corticosteroids are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Broadband and Narrowband UVB light treatments are generally safe for treating eczema. Studies have found these treatments to be well-tolerated and often used when other treatments prove insufficient.

For Broadband UVB, some individuals have reported mild skin irritation and a small chance of sunburn-like effects, though these are uncommon.

Narrowband UVB is also considered safe, with a low risk of side effects. Past patients have experienced fewer side effects, usually mild, such as skin irritation.

Both types of UVB light treatments have been used in people with eczema and are considered safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using broadband and narrowband UVB phototherapy for eczema because these treatments offer a non-invasive option that specifically targets the skin's inflammatory processes. Unlike traditional eczema treatments like topical steroids or calcineurin inhibitors, UVB phototherapy works by slowing down the growth of affected skin cells and reducing inflammation without the systemic side effects associated with oral medications. Additionally, narrowband UVB is particularly promising because it uses a specific wavelength of light that is more effective with fewer sessions, potentially leading to faster and longer-lasting relief for patients.

What evidence suggests that this trial's phototherapy treatments could be effective for eczema?

Research has shown that Narrowband UVB phototherapy, a treatment in this trial, effectively treats eczema. Studies found that about 93% of patients experienced good results, with at least a 50% reduction in symptoms, indicating improved skin condition and decreased inflammation. In comparison, Broadband UVB phototherapy, another treatment option in this trial, is less effective but still beneficial. It also reduces itching and inflammation, though Narrowband UVB generally works better for eczema. Both treatments help by adjusting the immune system, easing symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Aaron M Drucker

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My condition is severe despite using creams or ointments.

Your doctor has determined that your condition is severe, scoring 3 or 4 out of 4.

I have been diagnosed with atopic dermatitis.

Exclusion Criteria

I haven't taken biologic or experimental drugs in the last 90 days.

I haven't taken immune-modulating drugs or had phototherapy in the last 30 days.

I haven't taken oral or intramuscular steroids in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Narrowband or Broadband UVB phototherapy three times weekly

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Broadband UVB phototherapy
• Narrowband UVB phototherapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Narrowband UVB Active Control 1 Intervention

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

Group II: Broadband UVB Active Control 1 Intervention

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

Broadband UVB phototherapy is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Broadband UVB phototherapy for:

• Atopic dermatitis (eczema)

Approved in United States as Broadband UVB phototherapy for:

• Atopic dermatitis (eczema)
• Psoriasis
• Other skin conditions

Approved in European Union as Broadband UVB phototherapy for:

• Atopic dermatitis (eczema)
• Psoriasis
• Other skin conditions

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

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

Collaborator

Trials

476

Recruited

170,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Published Research Related to This Trial

Narrowband UVB (NB-UVB) has a significantly higher lethal dose (LD50) of 720 mJ cm(-2) compared to broadband UVB (BB-UVB) with an LD50 of 60 mJ cm(-2), indicating that NB-UVB is less phototoxic than BB-UVB.

The study utilized the photo hen's egg test (PHET) with 204 eggs to assess phototoxic effects, and the results align with existing literature showing that the minimal erythema dose (MED) for NB-UVB is up to 14 times higher than that of BB-UVB, suggesting NB-UVB may be a safer option for dermatological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phototoxicity of narrowband ultraviolet (UV) B (311 nm) compared with broadband UVB in the photo hen's egg test. Bafteh, PR., Siegesmund, M., Kuerten, V., et al.[2016]

In a study of 44 patients with atopic dermatitis, combining platelet-rich plasma (PRP) injections with narrowband-ultraviolet B (NB-UVB) treatment significantly improved skin condition, as shown by greater reductions in EASI and IGA scores compared to NB-UVB alone.

The addition of PRP not only enhanced the effectiveness of NB-UVB therapy but also shortened the treatment duration, potentially increasing patient compliance and making it a practical option for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible clinical efficacy and tolerability of platelet-rich plasma with atopic dermatitis. Yosef, A., Elkady, N., Khattab, F.[2021]

Narrowband ultraviolet B (nbUVB) phototherapy is a safe and effective treatment for children with atopic eczema, achieving complete or near-complete clearance in 52% of treated children, particularly those with higher skin phototypes (III to VI).

The treatment demonstrated high clinical remission rates at various follow-up intervals (100% at 0 months, 87% at 3 months, 57% at 6 months, and 52% at 12 months), with mild side effects reported in 28% of patients, suggesting it is a preferable second-line option over oral systemic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of paediatric eczema with narrowband ultraviolet light B therapy. Hunjan, MK., Brockley, JR., Buka, R., et al.[2021]

In a study of 117 patients treated with narrow-band ultraviolet B (NB-UVB) therapy, about 80% showed improvement in conditions like vitiligo and pruritus, indicating its efficacy as a treatment option.

NB-UVB therapy was well tolerated with no serious side effects reported, although some patients had mild issues like abnormal thyroid-stimulating hormone levels and anemia, suggesting it is a safe intervention for inflammatory skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrow-band ultraviolet B treatment for vitiligo, pruritus, and inflammatory dermatoses. Samson Yashar, S., Gielczyk, R., Scherschun, L., et al.[2021]

Narrowband ultraviolet B (NB-UVB) treatment resulted in a 61% reduction in eczema severity (measured by the SASSAD score) in 29 children, compared to a 6% increase in severity in a control group of 26 children who did not receive treatment.

The benefits of NB-UVB treatment not only improved objective eczema scores but also significantly enhanced quality of life, with effects lasting for at least 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrowband ultraviolet B phototherapy in children with moderate-to-severe eczema: a comparative cohort study. Darné, S., Leech, SN., Taylor, AE.[2022]

Narrowband UVB phototherapy is widely used for treating psoriasis, but there are concerns about its potential to increase the risk of nonmelanoma skin cancer (NMSC).

Mathematical models suggest that it will be challenging to definitively link narrowband UVB treatment to increased NMSC risk without large, long-term studies involving thousands of patients, as natural occurrence rates complicate the analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of follow-up in narrowband ultraviolet B phototherapy. Diffey, BL., Farr, PM.[2016]

In a randomized controlled trial involving 73 adult patients with moderate to severe atopic eczema, narrow-band UVB phototherapy significantly reduced disease activity and extent of disease compared to visible light, with mean reductions of 9.4 points and 6.7%, respectively.

Narrow-band UVB was found to be well tolerated, with only a small number of patients experiencing mild side effects like erythema or eczema flare-ups, indicating its safety as an adjunctive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial. Reynolds, NJ., Franklin, V., Gray, JC., et al.[2015]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11043791/

A Comprehensive Review of Phototherapy in Atopic Dermatitis

Utilizing narrowband UVB light, it exerts immunomodulatory effects to lessen inflammation and itching, crucial for AD management. It also ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34709669/

Phototherapy for atopic eczema

NB-UVB may increase the number of people reporting reduced itch after 12 weeks of treatment compared to placebo (risk ratio (RR) 1.72, 95% CI ...

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trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08334-z

The UPDATE trial (UVB Phototherapy in Dermatology for ...

The UPDATE trial aims to provide high-quality evidence regarding the (cost-)effectiveness and safety of NB-UVB phototherapy in moderate-to-severe AE patients.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S014067360005114X

Articles Narrow-band ultraviolet B and broad ...

Our study results indicate that narrow-band UVB phototherapy is an effective adjunctive treatment in moderate-to-severe adult atopic eczema.

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medicaljournalssweden.se

medicaljournalssweden.se/actadv/article/view/9403/19141

View of Narrowband-ultraviolet B vs Broadband- ...

Narrowband-ultraviolet B has shown increased efficacy over broadband-ultraviolet B in pruritic skin diseases, such as psoriasis and atopic ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4599569/

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Phototherapy is an optimal second-line treatment for AD. It can be used as monotherapy or in combination with systemic drugs, in particular corticosteroids.

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aetna.com

aetna.com/cpb/medical/data/200_299/0205.html

Phototherapy and Photochemotherapy (PUVA) for Skin ...

Generally 2 to 3 PUVA treatments per week for up to 23 weeks are considered medically necessary for psoriasis.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04818138

BROadband vs Narrowband photoTherapy for Eczema ...

The investigators will test to see which form of phototherapy (Broadband or Narrowband Ultraviolet B phototherapy) works best for eczema in a randomized ...