Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
研究概览
简要总结
Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.
详细描述
To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- ••Patients aged 18 years or more who diagnosed as bowen's disease
排除标准
- •pregnancy or lactation
- •active systemic infectious disease
- •other inflammatory, infectious, or neoplastic skin diseases in the treated area
- •allergy to MAL,other topical photosensitizers, or excipients of the cream
- •history of photosensitivity
- •use of immunosuppressive or photosensitizing drugs
- •participation in any other investigational study in the preceding 30 days
- •history or indicators of poor compliance
- •Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria
研究组 & 干预措施
MAL-PDT
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
干预措施: methyl-aminolevulinate application (Drug)
MAL-PDT
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
干预措施: Illuminating using red light-emitting diode lamps (Device)
AFL-PDT
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
干预措施: lidocaine-prilocaine 5% cream application (Drug)
AFL-PDT
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
干预措施: methyl-aminolevulinate application (Drug)
AFL-PDT
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
干预措施: Illuminating using red light-emitting diode lamps (Device)
结局指标
主要结局
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
时间窗: Short-term CR rate was evaluated at 3 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
时间窗: Long-term CR rate was evaluated at 60 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months
时间窗: Recurrent rate was evaluated at 60 months
In all cases of complete response, the patients were reviewed at 60 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
次要结局
- Difference of the cosmetic outcome between AFL-PDT and MAL-PDT(Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months)
研究者
Song Ki-Hoon
Associate professor
Dong-A University