None listed
Conditions
Brief summary
People who have experienced for the first time an episode of inflammation within the brain, spinal cord or optic nerves (called a first demyelinating event) are at risk of developing Multiple Sclerosis. In this study, we will test whether a course of narrow band UVB phototherapy decreases their risk of developing Multiple Sclerosis.
Interventions
Patients will be given narrow band (311 nm) UVB light to their full body on 3 occasions per week. Patients will receive a total of 24 administrations over 8 weeks. They will receive the narrow band UVB light as they stand up in a small cubicle. The exposure to the light will range from 1 to 4 minutes each time.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Recently diagnosed (within 120 days) with a first isolated, well-defined, uni- or multi-focal first demyelinating event (FDE). Able to receive their first phototherapy within 120 days of FDE symptom onset. An MRI brain scan that is supportive of demyelinating disease (Paty A or Paty B criteria, i.e. the presence of at least four T2 lesions greater than 3 mm, or at least three T2 lesions greater than 3 mm, one of which must be periventricular, respectively). An EDSS between 0 - 6.5 (inclusive) Must be able to give informed consent and sign the informed consent form Must be able to comply with all study procedures, and attend 24 phototherapy sessions and centres for venepuncture on multiple occasions during and after phototherapy If female of child-bearing age, must be willing to use effective contraception Must be willing to avoid use of sunbeds Must be able to stand in the phototherapy cubicle for up to 5 minutes at a time
Exclusion criteria
Known co-morbid illnesses that might be exacerbated by phototherapy, including lupus erythematosus and xeroderma pigmentosum A history of melanoma, multiple non melanoma skin cancers Previous prolonged courses of UVB or photochemotherapy (PUVA), or use of sunbeds Cardiovascular or respiratory disease that would prevent standing in the treatment cubicle Bullous disease Use of photosensitizing medications Very fair skin that burns with very minimal sun exposure (as judged by the dermatologist involved) Corticosteroids within 3 months, or current immunosuppressive drug therapy (beta-interferon, glatiramer acetate, natalizumab, mitoxantrone, or other chemotherapy agent specifically for demyelinating disease) prior to CIS diagnosis. (*Note that requirement for immunomodulatory therapy in the course of MS disease management will not exclude patients during follow-up; treatment variables will be collected and analysed in both the intervention and control arms in the planned analysis). Current pregnancy, breastfeeding or planning to become pregnant in the next 12 months. A second clinical demyelinating event prior to randomisation Concurrent diagnosis of other neurological, psychiatric or other disease, which, in the opinion of the investigator, could impair capacity to provide informed consent or interfere with study compliance. Current enrolment in another interventional trial Any contraindication to MRI scanning or intravenous Gadolinium including: Cardiac Pacemaker, Cardiac Defibrillator, Metal fragments in the eye, Any other non-MRI compatible medical device/implant or medical condition, Previous allergic reaction to Gadolinium, Severe claustrophobia
Outcome results
None listed