Ruiz Alberto J, LaRochelle Ethan P M, Fahrner Marie-Christine P, Emond Jennifer A, Samkoe Kimberley S, Pogue Brian W, Chapman M Shane
Thayer School of Engineering at Dartmouth Hanover New Hampshire USA.
Department of Dermatology Geisel School of Medicine at Dartmouth Hanover New Hampshire USA.
Skin Health Dis. 2023 Mar 31;3(4):e226. doi: 10.1002/ski2.226. eCollection 2023 Aug.
Photodynamic therapy (PDT) is widely used as a treatment for actinic keratoses (AK), with new sunlight-based regimens proposed as alternatives to lamp-based treatments. Prescribing indoor daylight activation could help address the seasonal temperature, clinical supervision, and access variability associated with outdoor treatments.
To compare the AK lesion clearance efficacy of indoor daylight PDT treatment (30 min of 5-aminolevulinic acid (ALA) pre-incubation, followed by 2 h of indoor sunlight) versus a lamp-based PDT treatment (30 min of ALA preincubation, followed by 10 min of red light).
A prospective clinical trial was conducted with 41 patients. Topical 10% ALA was applied to the entire treatment site (face, forehead, scalp). Patients were assigned to either the lamp-based or indoor daylight treatment. Actinic keratosis lesion counts were determined by clinical examination and recorded for pre-treatment, 1-month, and 6-month follow-up visits.
There was no statistical difference in the efficacy of AK lesion clearance between the red-lamp (1-month clearance = 57 ± 17%, 6-month clearance = 57 ± 20%) and indoor daylight treatment (1-month clearance = 61 ± 19%, 6-month clearance = 67 ± 20%). A 95% confidence interval of the difference of the means was measured between -4.4% and 13.4% for 1-month, and -2.2% and +23.6% for 6-month timepoints when comparing the indoor daylight to the red-lamp treatment, with a priori interval of equivalence of ±20%.
Ensuring an equivalent dose between the indoor and lamp treatment cohorts limited randomisation since it required performing indoor daylight treatments only during sunny days.
Indoor-daylight PDT provided equivalent AK treatment efficacy to a lamp-based regimen while overcoming temperature limitations and UV-block sunscreen issues associated with outdoor sunlight treatments in the winter.
Clinicaltrials.gov listing: NCT03805737.
光动力疗法（PDT）被广泛用于治疗光化性角化病（AK），新的基于阳光的治疗方案被提议作为基于灯的治疗方法的替代方案。规定室内日光激活有助于解决与室外治疗相关的季节温度、临床监督和可及性差异问题。
比较室内日光PDT治疗（5-氨基酮戊酸（ALA）预孵育30分钟，随后室内日光照射2小时）与基于灯的PDT治疗（ALA预孵育30分钟，随后红光照射10分钟）对AK病变的清除效果。
对41例患者进行了一项前瞻性临床试验。将10%的ALA局部应用于整个治疗部位（面部、前额、头皮）。患者被分配到基于灯的治疗组或室内日光治疗组。通过临床检查确定光化性角化病病变数量，并记录治疗前、1个月和6个月随访时的情况。
红灯治疗组（1个月清除率 = 57 ± 17%，6个月清除率 = 57 ± 20%）和室内日光治疗组（1个月清除率 = 61 ± 19%，6个月清除率 = 67 ± 20%）在AK病变清除效果上无统计学差异。将室内日光治疗与红灯治疗进行比较时，1个月时间点的平均差异的95%置信区间为-4.4%至13.4%，6个月时间点为-2.2%至+23.6%，预先设定的等效区间为±20%。
由于仅在晴天进行室内日光治疗，确保室内和灯治疗组之间的等效剂量限制了随机分组。
室内日光PDT与基于灯的治疗方案具有同等的AK治疗效果，同时克服了冬季与室外阳光治疗相关的温度限制和紫外线防护防晒霜问题。
Clinicaltrials.gov登记号：NCT03805737。
