Lecomte Fabienne, Vignion-Dewalle Anne Sophie, Vicentini Claire, Thecua Elise, Deleporte Pascal, Duhamel Alain, Mordon Serge, Mortier Laurent
U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.
Department of Dermatology, Centre Hospitalier et Universitaire de Lille, Université de Lille, Lille, France.
JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530.
Actinic keratosis (AK) is characterized by preinvasive, cancerous lesions on sun-exposed skin that negatively affect patient quality of life and may progress to invasive squamous cell carcinoma (SCC). If untreated, AK may either regress or progress to SCC, with significant morbidity and possible lethal outcomes. The most commonly used treatments for AK are cryotherapy, topical chemotherapy and, more recently, photodynamic therapy (PDT). This clinical study is part of a project that aims to create specific light-emitting fabrics (LEFs) that strongly improve the efficiency and reliability of PDT as a treatment for AK.
This study aims to compare the efficacy and tolerability of a new PDT protocol involving the Flexitheralight device (N-PDT) with the classical protocol involving the Aktilite CL 128 device (C-PDT; Galderma Laboratories) for the treatment of AK. All participants receive both protocols. The primary objective of this study is to compare the lesion response rate after 3 months of N-PDT with C-PDT. Secondary objectives are evaluations of pain and local tolerance during treatment, clinical evolution of the subject's skin, and evaluations of patient quality of life and satisfaction.
The study is a split-face, intraindividual comparison of two PDT protocols. The total number of patients recruited was 42. Patients were exposed to a continuous red light with the Aktilite CL 128 device on one side of the face and to fractionated red illumination with the new device, Flexitheralight, on the other side of the face. Males or females over the age of 18 years with a clinical diagnosis of at least 10 previously untreated, nonpigmented, nonhyperkeratotic grade I and II AK lesions of the forehead and/or scalp were included and were recruited from the Department of Dermatology of the Centre Hospitalier Universitaire de Lille. The patients came to the investigational center for one treatment session (day 1), and they were followed up after 7 days, 3 months and 6 months. A second treatment session was performed on day 111 in cases in which an incomplete response was observed at the 3-month follow-up. Data will be analyzed using SAS software version 9.4 (SAS Institute Inc). Continuous variables will be reported as means and standard deviations, and categorical variables will be reported as frequencies and percentages. The Shapiro-Wilk test will be used to assess the normality of the distribution.
The clinical investigation was performed by July 2018. Data analysis was performed at the end of 2018, and results are expected to be published in early 2019.
This phase II clinical trial aims to evaluate the noninferior efficacy and superior tolerability of N-PDT compared to that of C-PDT. If N-PDT is both efficacious and tolerable, N-PDT could become the treatment of choice for AK due to its ease of implementation in hospitals.
ClinicalTrials.gov NCT03076918; https://clinicaltrials.gov/ct2/show/NCT03076918 (archived by WebCite at http://www.webcitation.org/771KA0SSK).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11530.
光化性角化病（AK）的特征是在暴露于阳光的皮肤上出现癌前病变，这会对患者的生活质量产生负面影响，并可能发展为浸润性鳞状细胞癌（SCC）。如果不进行治疗，AK可能会消退或发展为SCC，从而导致严重的发病率和可能的致命后果。AK最常用的治疗方法是冷冻疗法、局部化疗，以及最近出现的光动力疗法（PDT）。这项临床研究是一个项目的一部分，该项目旨在制造特定的发光织物（LEF），以大幅提高PDT作为AK治疗方法的效率和可靠性。
本研究旨在比较一种新的使用Flexitheralight设备的PDT方案（N-PDT）与经典的使用Aktilite CL 128设备的方案（C-PDT；高德美实验室）在治疗AK方面的疗效和耐受性。所有参与者都接受这两种方案。本研究的主要目的是比较N-PDT与C-PDT治疗3个月后的皮损反应率。次要目的是评估治疗期间的疼痛和局部耐受性、受试者皮肤的临床演变情况，以及评估患者的生活质量和满意度。
该研究是对两种PDT方案进行的半脸、个体内比较。招募的患者总数为42名。患者一侧面部使用Aktilite CL 128设备接受连续红光照射，另一侧面部使用新设备Flexitheralight接受分次红光照射。纳入年龄在18岁以上、临床诊断为前额和/或头皮至少有10处先前未治疗的、无色素沉着、无角化过度的I级和II级AK皮损的男性或女性，这些患者来自里尔大学中心医院皮肤科。患者到研究中心接受一次治疗（第1天），并在7天、3个月和6个月后进行随访。在3个月随访时观察到反应不完全的病例，在第111天进行第二次治疗。数据将使用SAS 9.4版软件（SAS研究所）进行分析。连续变量将以均值和标准差报告，分类变量将以频率和百分比报告。将使用夏皮罗-威尔克检验来评估分布的正态性。
临床研究于2018年7月完成。数据分析于2018年底进行，结果预计于2019年初发表。
这项II期临床试验旨在评估N-PDT与C-PDT相比的非劣效性疗效和更好的耐受性。如果N-PDT既有效又耐受，由于其在医院易于实施，N-PDT可能会成为AK的首选治疗方法。
ClinicalTrials.gov NCT03076918；https://clinicaltrials.gov/ct2/show/NCT03076918（由WebCite存档于http://www.webcitation.org/771KA0SSK）。
国际注册报告识别码（IRRID）：DERR1-10.2196/11530。
