ACTRN12622001585718招募中2 期
Phase IIb open label randomised controlled trial of definitive volumetric modulated arc radiotherapy versus standard dermatological treatment for recalcitrant symptomatic rosacea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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