Wolfgang G Philipp-Dormston, Matthias Brückner, Matthias Hoffmann, Melvin Baé, Jörg Fränken, Bernd Großmann, Uwe Paasch, Sven Quist, Berenice M Lang, Rajeev Chavda, Rolf-Markus Szeimies
{"title":"在德国实际环境中使用氨基乙酰丙酸甲酯的人工日光光动力疗法--非干预性研究 ArtLight 的结果。","authors":"Wolfgang G Philipp-Dormston, Matthias Brückner, Matthias Hoffmann, Melvin Baé, Jörg Fränken, Bernd Großmann, Uwe Paasch, Sven Quist, Berenice M Lang, Rajeev Chavda, Rolf-Markus Szeimies","doi":"10.1093/bjd/ljae437","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Artificial daylight photodynamic therapy (ADL-PDT) is an alternative, all-year applicable, nearly painless treatment approach for actinic keratoses (AK) with comparable effectiveness to daylight or conventional PDT. At the time this study was initiated, methyl aminolevulinate (MAL) was the only photosensitizer approved for ADL-PDT in Germany.</p><p><strong>Objective: </strong>To gain comprehensive insights into the practicability of MAL-ADL-PDT in patients with AK using different artificial daylight sources under real-world conditions.</p><p><strong>Methods: </strong>This prospective, non-interventional, multicenter study (ArtLight, NCT05725213) enrolled patients with Olsen grade 1 or 2 AK on the face and scalp in Germany. Patients were treated with MAL-ADL-PDT (160mg/g MAL cream). The primary outcome measure was the practicability of MAL-ADL-PDT assessed as rate of resolved AK lesions in the focus area (10x10 cm area within the treatment area). Secondary outcomes included treatment-associated pain (numeric rating scale, NRS-11), Actinic Keratosis Area and Severity Index (AKASI), total lesion count over time, skin preparation, safety, overall assessment of effectiveness, tolerability, adherence, and patient satisfaction.</p><p><strong>Results: </strong>In total, 224 patients (median age: 75.0 years (range 50-91), 85.3% male, 62.5% AK Olsen grade 2, 55.4% treatment-naïve) were included and treated with MAL-ADL-PDT. Three months after treatment, lesion counts were reduced in the focus area by 71% (p<0.001) indicating practicability of the treatment. Nearly all patients (93.3%) experienced none or mild pain during PDT (NRS score 0-3). Median AKASI decreased from 6.2 at baseline to 3.4 at month 3 (95% CI 2.4-3.0; p<0.001). The majority of investigators (82.8%) and patients (80.0%) were satisfied with the treatment. No new safety signals were reported.</p><p><strong>Conclusions: </strong>The clinical practicability of MAL-ADL-PDT was demonstrated under real-world conditions by effective lesion reduction and predominantly none to mild procedural pain. Thus, MAL-ADL-PDT is a convenient way for healthcare professionals to deliver PDT treatment to patients with AK located on the face and scalp.</p>","PeriodicalId":9238,"journal":{"name":"British Journal of Dermatology","volume":" ","pages":""},"PeriodicalIF":11.0000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Artificial daylight photodynamic therapy using methyl aminolevulinate in a real-world setting in Germany - Results from the non-interventional study ArtLight.\",\"authors\":\"Wolfgang G Philipp-Dormston, Matthias Brückner, Matthias Hoffmann, Melvin Baé, Jörg Fränken, Bernd Großmann, Uwe Paasch, Sven Quist, Berenice M Lang, Rajeev Chavda, Rolf-Markus Szeimies\",\"doi\":\"10.1093/bjd/ljae437\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Artificial daylight photodynamic therapy (ADL-PDT) is an alternative, all-year applicable, nearly painless treatment approach for actinic keratoses (AK) with comparable effectiveness to daylight or conventional PDT. At the time this study was initiated, methyl aminolevulinate (MAL) was the only photosensitizer approved for ADL-PDT in Germany.</p><p><strong>Objective: </strong>To gain comprehensive insights into the practicability of MAL-ADL-PDT in patients with AK using different artificial daylight sources under real-world conditions.</p><p><strong>Methods: </strong>This prospective, non-interventional, multicenter study (ArtLight, NCT05725213) enrolled patients with Olsen grade 1 or 2 AK on the face and scalp in Germany. Patients were treated with MAL-ADL-PDT (160mg/g MAL cream). The primary outcome measure was the practicability of MAL-ADL-PDT assessed as rate of resolved AK lesions in the focus area (10x10 cm area within the treatment area). Secondary outcomes included treatment-associated pain (numeric rating scale, NRS-11), Actinic Keratosis Area and Severity Index (AKASI), total lesion count over time, skin preparation, safety, overall assessment of effectiveness, tolerability, adherence, and patient satisfaction.</p><p><strong>Results: </strong>In total, 224 patients (median age: 75.0 years (range 50-91), 85.3% male, 62.5% AK Olsen grade 2, 55.4% treatment-naïve) were included and treated with MAL-ADL-PDT. Three months after treatment, lesion counts were reduced in the focus area by 71% (p<0.001) indicating practicability of the treatment. Nearly all patients (93.3%) experienced none or mild pain during PDT (NRS score 0-3). Median AKASI decreased from 6.2 at baseline to 3.4 at month 3 (95% CI 2.4-3.0; p<0.001). The majority of investigators (82.8%) and patients (80.0%) were satisfied with the treatment. No new safety signals were reported.</p><p><strong>Conclusions: </strong>The clinical practicability of MAL-ADL-PDT was demonstrated under real-world conditions by effective lesion reduction and predominantly none to mild procedural pain. Thus, MAL-ADL-PDT is a convenient way for healthcare professionals to deliver PDT treatment to patients with AK located on the face and scalp.</p>\",\"PeriodicalId\":9238,\"journal\":{\"name\":\"British Journal of Dermatology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":11.0000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjd/ljae437\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjd/ljae437","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景:人工日光光动力疗法(ADL-PDT)是治疗光化性角化病(AK)的另一种全年适用、几乎无痛的治疗方法,其疗效与日光或传统光动力疗法相当。本研究启动时,氨基乙酰丙酸甲酯(MAL)是德国唯一批准用于 ADL-PDT 的光敏剂:目的:全面了解在真实世界条件下使用不同的人造光源对 AK 患者进行 MAL-ADL-PDT 治疗的实用性:这项前瞻性、非干预性、多中心研究(ArtLight,NCT05725213)招募了德国面部和头皮奥尔森1级或2级AK患者。患者接受了 MAL-ADL-PDT 治疗(160 毫克/克 MAL 霜)。主要结果是MAL-ADL-PDT的实用性,评估指标是病灶区(治疗区内10x10厘米的区域)AK病变的消退率。次要结果包括治疗相关疼痛(数字评分量表,NRS-11)、角化病面积和严重程度指数(AKASI)、随时间变化的皮损总数、皮肤准备、安全性、疗效总体评估、耐受性、依从性和患者满意度:共有 224 名患者(中位年龄:75.0 岁(50-91 岁不等),85.3% 为男性,62.5% 为 AK 奥尔森 2 级,55.4% 为治疗无效患者)接受了 MAL-ADL-PDT 治疗。治疗三个月后,病灶区的皮损数量减少了71%(p结论:MAL-ADL-PDT治疗的临床实用性与AK-Olsen分级2的临床疗效一致:MAL-ADL-PDT的临床实用性在实际条件下得到了证实,它能有效减少病变,而且治疗过程中主要没有疼痛,只有轻微疼痛。因此,MAL-ADL-PDT 是医护人员为面部和头皮 AK 患者提供 PDT 治疗的一种便捷方法。
Artificial daylight photodynamic therapy using methyl aminolevulinate in a real-world setting in Germany - Results from the non-interventional study ArtLight.
Background: Artificial daylight photodynamic therapy (ADL-PDT) is an alternative, all-year applicable, nearly painless treatment approach for actinic keratoses (AK) with comparable effectiveness to daylight or conventional PDT. At the time this study was initiated, methyl aminolevulinate (MAL) was the only photosensitizer approved for ADL-PDT in Germany.
Objective: To gain comprehensive insights into the practicability of MAL-ADL-PDT in patients with AK using different artificial daylight sources under real-world conditions.
Methods: This prospective, non-interventional, multicenter study (ArtLight, NCT05725213) enrolled patients with Olsen grade 1 or 2 AK on the face and scalp in Germany. Patients were treated with MAL-ADL-PDT (160mg/g MAL cream). The primary outcome measure was the practicability of MAL-ADL-PDT assessed as rate of resolved AK lesions in the focus area (10x10 cm area within the treatment area). Secondary outcomes included treatment-associated pain (numeric rating scale, NRS-11), Actinic Keratosis Area and Severity Index (AKASI), total lesion count over time, skin preparation, safety, overall assessment of effectiveness, tolerability, adherence, and patient satisfaction.
Results: In total, 224 patients (median age: 75.0 years (range 50-91), 85.3% male, 62.5% AK Olsen grade 2, 55.4% treatment-naïve) were included and treated with MAL-ADL-PDT. Three months after treatment, lesion counts were reduced in the focus area by 71% (p<0.001) indicating practicability of the treatment. Nearly all patients (93.3%) experienced none or mild pain during PDT (NRS score 0-3). Median AKASI decreased from 6.2 at baseline to 3.4 at month 3 (95% CI 2.4-3.0; p<0.001). The majority of investigators (82.8%) and patients (80.0%) were satisfied with the treatment. No new safety signals were reported.
Conclusions: The clinical practicability of MAL-ADL-PDT was demonstrated under real-world conditions by effective lesion reduction and predominantly none to mild procedural pain. Thus, MAL-ADL-PDT is a convenient way for healthcare professionals to deliver PDT treatment to patients with AK located on the face and scalp.
期刊介绍:
The British Journal of Dermatology (BJD) is committed to publishing the highest quality dermatological research. Through its publications, the journal seeks to advance the understanding, management, and treatment of skin diseases, ultimately aiming to improve patient outcomes.