ACTRN12612000257864已完成2 期
In patients receiving treatment for solar dermopathy with photodynamic therapy (PDT) does PDT-eze compared with no PDT-eze improve pain difference scores.
Peter Smith0 个研究点目标入组 60 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
se of a simple, plant derived anti-nociceptive spray can reduce the discomfort experienced by patients undergoing photodynamic therapy to large areas.
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
- 21 Years 至 o limit（—）
- 性别
- All
入选标准
- •*All patients male or female older than 21 with mild to moderate solar dermopathy of their face or forearms in whom the managing clinician feels photodynamic therapy to be an appropriate treatment modality
- •*Must have indicated a willingness to enter the study
- •*Must have read and fully understood a study information form
- •*Must have had the opportunity to ask any questions prior to enrolment
- •*Must have signed study consent form
排除标准
- •*Any contraindications to PDT
- •*Having received PDT to the treatment area in the last 2years
- •*Any history of reaction or intolerance to menthol/ginseng mixture or the standard PDT preparation and treatment formulations - alpha hydroxy acid preparations at 10 and 15%.
- •*Any obvious cutaneous malignancies in the area to receive PDT (these must be appropriately managed before consideration of enrolment in the trial)
- •*Pregnancy
研究者
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