Dermatology Clinic, University La Sapienza, Rome, Italy.
Dermatology Clinic, Catholic University, Rome, Italy.
Photodermatol Photoimmunol Photomed. 2023 Jul;39(4):384-391. doi: 10.1111/phpp.12870. Epub 2023 Mar 31.
This study describes a prospective, multicentre, randomized controlled, open-label study with three arms aimed at studying the differences between: [Cnt], self-administered sun protection; [T], topical treatment; and [TO], topical + oral treatment; for the management of Actinic Keratosis (AK) in a cohort of subjects of advanced age displaying severe actinic damage (SAD).
Treatments administered to groups [T] and [TO] had a common component, which is a botanical extract, Fernblock, with demonstrated photoprotective activity.
In total, 131 subjects were distributed randomly in the three groups, and followed up clinically at three separate time points, beginning of the study (t = 0) and after 6 and 12 months. Analysis of clinical data and examination using reflectance confocal microscopy (RCM) revealed that group [T] and [TO] displayed decreased clinical AK and field cancerization parameters, including the number of new lesions, and reduced the need for additional interventions in these patients. RCM revealed normalization of the keratinocyte layer. Improvements in AK and field cancerization parameters were greatest in the group [TO], suggesting that topical and oral photoprotection improves the clinical and anatomical outcome compared to control conditions.
The combination of topical and oral immune photoprotection provides an advantage compared to topical photoprotection alone.
本研究描述了一项前瞻性、多中心、随机对照、开放性研究,分为三组,旨在研究以下三组之间的差异:[Cnt],自我管理的防晒措施;[T],局部治疗;[TO],局部+口服治疗;用于治疗年龄较大且有严重光损伤(SAD)的受试者队列中的光化性角化病(AK)。
[T]组和[TO]组的治疗方法有一个共同的组成部分,即具有明显光保护活性的植物提取物 Fernblock。
共 131 名受试者随机分配到三组中,并在三个不同的时间点进行临床随访,分别为研究开始时(t=0)、6 个月和 12 个月。临床数据和反射共聚焦显微镜(RCM)检查结果显示,[T]组和[TO]组的 AK 临床和癌前病变参数减少,包括新发病变数量减少,并且这些患者需要的额外干预减少。RCM 显示角朊细胞层正常化。[TO]组的 AK 和癌前病变参数改善最大,表明与对照条件相比,局部和口服免疫防晒联合治疗可改善临床和解剖结果。
与单纯局部防晒相比,局部和口服联合免疫防晒具有优势。