None listed
Conditions
Brief summary
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.
Interventions
ARM B: Volumetric Modulated Arc Therapy (VMAT): 36Gy in 20 once daily fractions delivered within a period of eight weeks in total inclusive of a mid-treatment break of a minimum two weeks.
Patients are required to attend a treatment planning session that will assist with planning the treatment. The planning procedure will take up to approximately 60 minutes and involve a computed-tomography (CT) scan with the patient positioned in the treatment position.
Treatment is expected to take around 15
ARM B: Volumetric Modulated Arc Therapy (VMAT): 36Gy in 20 once daily fractions delivered within a period of eight weeks in total inclusive of a mid-treatment break of a minimum two weeks. Patients are required to attend a treatment planning session that will assist with planning the treatment. The planning procedure will take up to approximately 60 minutes and involve a computed-tomography (CT) scan with the patient positioned in the treatment position. Treatment is expected to take around 15 minutes per treatment. The intervention will be prescribed by a radiation oncologist and administered by radiation therapists. Patients will commence treatment within four (4) weeks or randomisation and there will be approximately one (1) to two (2) weeks from the time of simulation to the commencement of radiotherapy. During treatment, imaging will be completed to ensure treatment is administered accurately. All patients will complete quality of life.
Sponsors
Icon Cancer Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
50 years of age or over. Recalcitrant and relapsing rosacea, defined as those who have suffered with rosacea for at least 10 years and have relapsed following treatment with at least one standard systemic therapy and one standard topical therapy. Prior therapy must have been administered for at least 12 weeks. Rosacea score of 3-4 as defined by the IGA scale for rosacea. Able to have punch biopsies as described for the translational component of the study. Able to receive VMAT RT to 36 Gy in 20 fractions within 8weeks for this condition. Willing and able to give written informed consent. Willing and able to participate in and comply with the study procedures and follow-up schedule. Life expectancy of over 2 years.
Exclusion criteria
Rosacea where Telangiectasia is the primary feature. History of a radiation sensitivity syndrome. Previous in-field RT. Previous in-field invasive skin cancer treated within 4 weeks of enrolment. Human Immunodeficiency Virus infection.
Outcome results
None listed