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

Phase 2

Recruiting

• Conditions: Recalcitrant Rosacea; Skin - Dermatological conditions

• Registration Number: ACTRN12622001585718
• Lead Sponsor: Icon Cancer Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-22
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

60 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 systemic therapy and one 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 in 4-8weeks 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.
Rosacea which involves the forehead.
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of VMAT compared to the dermatological standard of care at 12 months post-randomisation measured by a the incidence of in-field failure within 12 months of randomisation. This will be assessed through use of the Investigator global assessment (IGA) scale for Rosacea. Failure is defined as a subsequent increase to an IGA score of 2 or higher following initial clearance of significant rosacea or patients who do not have any clearance of significant rosacea within 12 months. [ Assessed 12 months following date of randomisation. ]