Simulated daylight vs. conventional PDT for clinical superficial BCC: A randomized controlled trial.

IF 8.4 2区医学 Q1 DERMATOLOGY

Journal of the European Academy of Dermatology and Venereology Pub Date : 2025-02-18 DOI:10.1111/jdv.20602

Alexandra Sjöholm, Eva Backman, Maja Modin, Julia Fougelberg, Magdalena Claeson, John Paoli

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引用次数: 0

Abstract

Background: Photodynamic therapy (PDT) is a recognized treatment for superficial basal cell carcinoma (sBCC). Conventional PDT (C-PDT) has a relatively high clearance rate but is time-consuming and painful. Simulated daylight PDT (SDL-PDT) has the potential advantage of causing less pain, but its effectiveness has not been investigated thoroughly.

Objectives: To determine whether SDL-PDT is non-inferior to C-PDT in the treatment of clinically diagnosed sBCC and to assess adverse events during treatment and patient preferences.

Methods: In this single-centre, non-inferiority, randomized controlled trial, adult patients with sBCCs of any size and located on anatomical sites suitable for PDT were recruited. Lesions were randomized to two sessions of either SDL-PDT or C-PDT using aminolevulinic acid as the photosensitizer. Patient-perceived pain was measured using a numeric rating scale (NRS) ranging from 0 to 10. Self-report forms were used to measure patient preferences. Patients were evaluated after 3 months to assess early treatment failure and after 1 year to determine overall clearance rates.

Results: In total, 78 participants with 193 sBCCs were treated. Most lesions (47.2%) were located on the trunk and were diagnosed solely through dermoscopic evaluation (64.2%). After 1 year, the clearance rate was 62.4% for SDL-PDT and 91.8% for C-PDT (p < 0.001) disproving non-inferiority. Illumination was reported to be more painful during C-PDT (mean NRS score of 3.5 at session 1 and 3.7 at session 2) compared with SDL-PDT (mean NRS score of 0.1 at both sessions) (p < 0.001). Immediately after treatment, 87.5% of respondents expressed a preference for SDL-PDT.

Conclusions: SDL-PDT is less effective than C-PDT but is also less painful. Due to the lower clearance rate, this study does not support SDL-PDT as a primary treatment option for sBCC. The randomized controlled trial was registered at http://www.researchweb.org/ (project 264721).

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背景：光动力疗法（PDT）是公认的浅表基底细胞癌（sBCC）治疗方法。传统的光动力疗法（C-PDT）清除率相对较高，但费时且痛苦。模拟日光光导疗法（SDL-PDT）的潜在优势是疼痛较少，但其有效性尚未得到深入研究：目的：确定在治疗临床诊断的 sBCC 时，SDL-PDT 是否不逊于 C-PDT，并评估治疗期间的不良反应和患者的偏好：在这项单中心、非劣效性、随机对照试验中，招募了sBCC成年患者，他们的sBCC大小不限，位于适合PDT的解剖部位。病变部位被随机分为 SDL-PDT 或 C-PDT（使用氨基乙酰丙酸作为光敏剂）两个疗程。患者的疼痛感采用 0-10 分的数字评分表（NRS）进行测量。使用自我报告表测量患者的偏好。3 个月后对患者进行评估，以评估早期治疗失败情况，1 年后对患者进行评估，以确定总体清除率：共有 78 名患者接受了治疗，共治疗了 193 个 sBCC。大多数病灶（47.2%）位于躯干，仅通过皮肤镜评估确诊（64.2%）。1 年后，SDL-PDT 的清除率为 62.4%，C-PDT 为 91.8%（P 结论：SDL-PDT 比 C-PDT 更有效：SDL-PDT的疗效低于C-PDT，但痛苦也较小。由于清除率较低，本研究不支持将 SDL-PDT 作为 sBCC 的主要治疗方案。该随机对照试验已在 http://www.researchweb.org/（项目编号 264721）上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the European Academy of Dermatology and Venereology 医学-皮肤病学

CiteScore

10.70

自引率

8.70%

发文量

874

审稿时长

3-6 weeks

期刊介绍： The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV). The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology. The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.