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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment for eczema?

Narrowband ultraviolet B (NB-UVB) therapy is a well-established and effective treatment for eczema, as well as other skin conditions like psoriasis and vitiligo. Studies suggest that NB-UVB is more effective than broadband UVB (BB-UVB) for these conditions. ^{1 2 3 4 5}

Is light therapy safe for treating eczema?

Light therapy, including both broadband and narrowband UVB, is generally considered safe for treating skin conditions like eczema, but there is some concern about a potential increased risk of skin cancer with narrowband UVB. ^{1 2 4 6 7}

How is light therapy for eczema different from other treatments?

Light therapy for eczema, specifically using narrowband UVB (NB-UVB), is unique because it uses a specific wavelength of ultraviolet light to reduce inflammation and improve skin conditions. This treatment is particularly effective for moderate to severe cases and is often used when other treatments have not worked well. ^{1 2 3 4 5}

Research Team

Aaron M Drucker

Principal Investigator

Women's College Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of paediatric eczema with narrowband ultraviolet light B therapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Narrowband ultraviolet B phototherapy in children with moderate-to-severe eczema: a comparative cohort study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Phototoxicity of narrowband ultraviolet (UV) B (311 nm) compared with broadband UVB in the photo hen's egg test. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Narrow-band ultraviolet B treatment for vitiligo, pruritus, and inflammatory dermatoses. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Possible clinical efficacy and tolerability of platelet-rich plasma with atopic dermatitis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The challenge of follow-up in narrowband ultraviolet B phototherapy. [2016]