Kohl E, Koller M, Zeman F, Szeimies R-M, Philipp-Dormston W G, Prager W, Gerber P A, Karrer S
Department of Dermatology, University Hospital Regensburg, 93042, Regensburg, Germany.
Center for Clinical Studies, University Hospital Regensburg, 93042, Regensburg, Germany.
BMC Dermatol. 2017 Oct 25;17(1):12. doi: 10.1186/s12895-017-0064-7.
Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated.
METHODS/DESIGN: In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to two treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group (experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After preparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h. In the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new AK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing and new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by means of a modified Dover scale. Primary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6. Secondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic results independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient and physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality Index). Safety parameters are also documented (adverse events and serious adverse events).
This clinical trial will assess the efficacy of repetitive DL-PDT in preventing AK and investigate possible rejuvenating effects of this treatment. (Trial registration: ClinicalTrials.gov Identifier: NCT02736760).
ClinicalTrials.gov Identifier: NCT02736760 . Study Code Daylight_01. EudraCT 2014-005121-13.
日光光动力疗法（DL-PDT）在治疗光化性角化病（AK）方面有效，但尚未研究对面部光损伤皮肤进行区域定向、重复DL-PDT治疗和预防AK的疗效。
方法/设计：在这项多中心、前瞻性、随机、对照、双臂、观察者盲法试验中，面部光损伤皮肤有至少5处轻度至中度AK皮损的患者被随机分配到两个治疗组：用甲基氨基酮戊酸（MAL）进行的DL-PDT组和冷冻手术组。在DL-PDT组（实验组），在18个月内对面部进行5次治疗。在皮损准备好且MAL应用后30分钟内，患者暴露于日光下2小时。在对照组，首次就诊时进行皮损定向冷冻手术，如果AK皮损未清除或出现新的皮损，则在第2至5次就诊时也进行冷冻手术。在第2至6次就诊时，通过记录面部所有现有的和新出现的AK皮损来评估治疗效果。通过改良的多佛量表评估美容效果和光老化参数的改善情况。主要结局参数是第2至6次就诊期间观察到的AK皮损累积数量。次要结局参数包括AK的完全清除、自上次就诊以来新出现的AK皮损、患者和医生独立评估的美容效果、患者报告的疼痛（视觉模拟量表）、患者和医生对美容效果的满意度评分以及患者报告的生活质量（皮肤病生活质量指数）。还记录安全参数（不良事件和严重不良事件）。
本临床试验将评估重复DL-PDT预防AK的疗效，并研究该治疗可能的年轻化效果。（试验注册号：ClinicalTrials.gov标识符：NCT02736760）。
ClinicalTrials.gov标识符：NCT02736760。研究代码Daylight_01。欧盟临床试验注册号2014-005121-13。
