ROSEND
ROSEND: A Randomised trial for the treatment of recalcitrant symptomatic rosacea using definitive volumetric modulated arc radiotherapy or standard dermatological treatment
Trial 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.
Receptor status / problem studied:
Inclusion criteria
1) 60 years of age or over.
2) 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 systemic therapy and one topical therapy. Prior therapy must have been administered for at least 12 weeks.
3) Rosacea score of 3-4 as defined by the IGA scale for rosacea.
4) Able to have punch biopsies as described for the translational component of the study.
5) Able to receive VMAT RT to 36 Gy in 20 fractions in 4-8weeks for this condition.
6) Willing and able to give written informed consent.
7) Willing and able to participate in and comply with the study procedures and follow-up schedule.
8) Life expectancy of over 2 years.
Exclusion criteria
1) Rosacea where Telangiectasia is the primary feature.
2) Rosacea which involves the forehead.
3) History of a radiation sensitivity syndrome.
4) Previous in-field RT.
5) Previous in-field invasive skin cancer treated within 4 weeks of enrolment.
6) Human Immunodeficiency Virus infection.
Trial Title
ROSEND
Diagnosis
Skin cancer – non-melanoma
Type of trial
Investigator Initiated
Type of treatement
Radiation Oncology
Phase
II