A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 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
Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.
详细描述
Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.
Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.
Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.
Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:
- •tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
- •difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)
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
AFL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
干预措施: lidocaine-prilocaine 5% cream application (Drug)
AFL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
干预措施: methyl-aminolevulinate application (Drug)
AFL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
干预措施: Illuminating using red light-emitting diode lamps (Device)
MAL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
干预措施: methyl-aminolevulinate application (Drug)
MAL-PDT
Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
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 recurrence rate at 24 months
时间窗: Recurrent rate was evaluated at 24months
In all cases of complete response, the patients were reviewed at 24 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
时间窗: Long-term CR rate was evaluated at 24 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
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 24 months)
研究者
Song Ki-Hoon
Associate professor
Dong-A University