The ROSEND Trial - A Randomised trial for the treatment of recalcitrant symptomatic rosacea using definitive volumetric modulated arc radiotherapy or standard dermatological treatment

The ROSEND clinical trial aims to compare standard of care dermatological treatment with a specialised type of radiotherapy called volumetric modulated arc radiotherapy (VMAT) in patients who suffer from chronic, recurrent rosacea. The study hypothesis is that VMAT will lead to a significantly lower rate of return of rosacea in the treatment area within 12 months of randomisation. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with chronic, recurrent, moderate to severe rosacea for at least 10 years and have relapsed following treatment with at least one systemic therapy and one topical therapy. Study details Participants will be randomly assigned to either standard of care dermatological treatment or VMAT as part of this study. In Arm A, called the current standard of care, treatment will be one or a combination of the standard dermatological treatments which will involve; topical therapy applied for a minimum of 16 weeks (Metronidazole (0.75%) gel or cream, applied once or twice daily or Ivermectin (1%) cream applied once daily), and/or Vascular laser or Intense pulse light treatment – limited to three episodes of treatment, with a maximum of four weeks between each episode, and/or Oral antibiotic therapy (Doxycycline 50-100 mg per day or Minocycline 50-200 mg per day) taken for a minimum of eight weeks. All patients will complete quality of life and a medication diary. In Arm B, called Volumetric Modulated Arc Therapy (VMAT), participants will be given 20 treatments in once daily fractions delivered within a period of eight (8) weeks in total inclusive of a mid-treatment break of a minimum of two (2) weeks. Each treatment will take around 15 to 20 minutes. A medication diary (for arm A patients only) and questionnaires will be completed at the initial assessment, last day of treatment, 4 weeks after radiotherapy and at 3, 6, 9, 12, 18 and 24 months following the date of randomisation.