Carac & PDT Combination in the Treatment Of Actinic Keratoses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Reduction of Actinic Keratoses
研究概览
简要总结
To demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone. This will be done by manual counts and through photography.
详细描述
Carac has been shown to be highly effective for the treatment of actinic keratoses. Photodynamic Therapy (PDT) has also been shown to be highly effective for the treatment of actinic keratoses. Both treatments are FDA approved. The mechanism of action of each therapy is different. In general a more vigorous, but less cosmetically acceptable appearance is seen after Carac treatment as compared to PDT treatment. The purposes of this study are to determine 1) If the use of Carac, followed by PDT treatment, of actinic keratoses leads to an enhanced clinical improvement as compared to PDT treatment alone; 2) If the cosmetic appearance of the skin during Carac is improved with PDT pre-treatment; 3) Evaluate histologic changes induced by combined Carac/PDT treatment as compared to Carac treatment alone and PDT treatment alone.;4) Evaluate safety of treatments in terms of potential for infection and scarring
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males/females,, aged 40-70
- •Must have 5 or more documented facial/anterior scalp actinic keratoses
- •Read, understood, and signed informed consent form
- •Willing and able to comply with all follow-up requirements
排除标准
- •Previous treatment of facial keratoses with any modality of treatment within 3 months of study enrollment
- •Contraindications to the use of either Carac and/or PDT treatment
- •Exclusion of biopsy proven skin cancer in the area
- •Active infections or dermatitis in the treatment area
研究组 & 干预措施
1
Carac
干预措施: Fluorouracil (Drug)
2
Photodynamic Therapy
干预措施: Photodynamic therapy (Procedure)
3
Carac combined with Photodynamic Therapy
干预措施: Carac in combination with PDT (Procedure)
结局指标
主要结局
Reduction of Actinic Keratoses
时间窗: Outcomes are assessed at 3 months
The objective of this study is to demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone based on a manual lesion count.
次要结局
- Photographic Improvement of Actinic Keratoses(Outcomes are assessed at 3 months)