RecruitingPhase 2ACTRN12615000802505

Narrow band ultraviolet B (UVB) phototherapy in amyotrophic lateral sclerosis

A Phase IIA trial in amyotrophic lateral sclerosis of the safety and biological efficacy (increase in regulatory T cells) of narrow-band UVB phototherapy plus standard-of-care compared to standard-of-care only.

Sponsor

Western Sydney Local Health District

Enrollment

20 participants

Start Date

Aug 6, 2015

Study Type

Interventional

Conditions

Amyotrophic Lateral Sclerosis

Summary

While the cause of amyotrophic lateral sclerosis (ALS) is unknown, recent evidence points to an important role for immune dysregulation in ALS disease. In particular, a role for the suppressive arm of the immune system, directed primarily by regulatory T cells (Tregs), may slow disease progression. In this project we will conduct the first trial in ALS of a specific immune therapy, narrow band UVB phototherapy, known to increase Treg activity. Narrow band UVB phototherapy is a simple, safe and non-invasive treatment used routinely to suppress damaging immune reactions in other conditions such as psoriasis. We will determine whether UVB phototherapy is safe in ALS and whether it induces regulatory T cells. If effective, this would support a larger trial examining whether UVB phototherapy can slow the progression of disease. Slowing disease progression using phototherapy would be a major advance for this disease. If phototherapy has no effect on disease progression but can increase regulatory T cells it may be useful in combination with other neuron-regenerating treatments that are in development, by reducing immune-mediated neuron damage. The study proposed here will expand our knowledge of the role of the immune system in ALS and highlight the potential to harness its regulatory arm to slow disease progress.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a type of light treatment called narrow band UVB phototherapy — the same light used for skin conditions like psoriasis — can help slow the progression of ALS (also called motor neurone disease). Researchers believe this light treatment may boost a part of the immune system that could help protect nerve cells. The study will check whether the treatment is safe for people with ALS and whether it activates the right immune cells. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with ALS (possible, probable, or definite) - Your ALS functional rating score is 38 or higher (relatively mild to moderate disease) - You are able to stand in a treatment booth for up to 10 minutes and attend 36 sessions You may NOT be eligible if: - You have a condition that prevents you from standing in the treatment booth - You have an autoimmune condition or take immunosuppressive medicines - You are pregnant or planning to become pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1: Standard care plus Intervention Intervention: Phototherapy using a Waldmann UV7002 (TL01) phototherapy cabinet with output (between wavelengths 311-312 nm) of 0.6 mW/cm2 will be used. Eye prot

Arm 1: Standard care plus Intervention Intervention: Phototherapy using a Waldmann UV7002 (TL01) phototherapy cabinet with output (between wavelengths 311-312 nm) of 0.6 mW/cm2 will be used. Eye protection will be with a full face mask. Phototherapy will be given three times/week for twelve weeks (36 exposures in total). Phototherapy will be delivered according to the patient’s skin type using the psoriasis protocol recommended by Waldmann. The starting dose of 0.1 - 0.4 J/cm2 will be based on the skin type and will be well below the likely erythema threshold. All patients will receive 20% increments on their initial dose, up to a maximal dose of 2.0 - 3.0 J/cm2 dependent upon skin type, similar to that previously published (Paul et al, (2012) J Eur Acad Dermatol Venereol, 26 Suppl 3, 1-10). At each visit the dose will be given and any adverse effects will be recorded. The time of each UVB exposure varies from approximately 1 to approximately 4 minutes, with increasing lengths of exposure over time on therapy as the skin becomes tanned. Patient calendars, reminder phonecalls and free dedicated parking at the hospital will be provided to improve adherence to the intervention. Arm 2: Standard care.