Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.
U Reinhold, W G Philipp-Dormston, T Dirschka, R Ostendorf, R Aschoff, C Berking, A Jäger, B Schmitz, M Foguet, R-M Szeimies
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引用次数: 0
Abstract
Background: In actinic keratosis (AK), field cancerization describes areas of skin where multiple visible AK lesions are surrounded by healthy looking skin containing non-visible (subclinical) lesions. As all AK lesions have a risk of progression to cutaneous squamous cell carcinoma, experts advise field-directed treatment. Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce.
Objectives: This publication presents follow-up data of a phase III study evaluating the efficacy and safety of field-directed PDT.
Methods: The study was conducted in seven centres in Germany. For PDT, participants with AKs on the face and scalp (treatment area of 20 cm2) had received up to two field-directed PDTs using BF-200 ALA or placebo, and illumination with narrow-spectrum red light. Only participants or lesions with complete response 12 weeks after the last PDT were assessed for recurrences. The treatment area was evaluated 6 and 12 months after the last PDT for recurrence, cosmetic outcome and new lesions.
Results: Fifty-four participants in the BF-200 ALA and 30 in the placebo group entered the follow-up. The probability of a participant to be initially completely cleared and to remain cleared for 12 months was 57.4% for BF-200 ALA versus 20.0% for placebo. The probability of a lesion to be initially cleared and remain cleared for 12 months was 85.4% for BF-200 ALA versus 31.5% for placebo. 83.3% of participants with cosmetic impairment at baseline rated the cosmetic outcome 12 months after PDT with BF-200 ALA as very good or good. All parameters of skin quality further improved during follow-up.
Conclusions: We showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients.
背景：在光化性角化病（AK）中，视野癌化指的是在多处可见 AK 病变的皮肤区域，周围是含有非可见（亚临床）病变的健康皮肤。由于所有 AK 病变都有发展为皮肤鳞状细胞癌的风险，专家建议进行野外定向治疗。光动力疗法（PDT）是治疗 AK 的一种有效的现场定向治疗方法，但长期疗效数据仍然很少：本刊物介绍了一项评估野外定向光动力疗法疗效和安全性的 III 期研究的随访数据：该研究在德国的七个中心进行。面部和头皮AK患者（治疗面积为20平方厘米）最多接受两次野外定向PDT治疗，使用BF-200 ALA或安慰剂，并用窄光谱红光照射。只有在最后一次光导治疗 12 周后出现完全反应的参与者或病灶才会接受复发评估。最后一次光动力疗法后 6 个月和 12 个月，对治疗区域的复发、美容效果和新病变进行评估：结果：BF-200 ALA 组和安慰剂组分别有 54 人和 30 人接受了随访。BF-200 ALA 最初完全清除并在 12 个月内保持清除的概率为 57.4%，而安慰剂为 20.0%。BF-200 ALA 最初清除病灶并在 12 个月内保持清除的概率为 85.4%，安慰剂为 31.5%。83.3% 的基线美容受损参与者在使用 BF-200 ALA 进行光导治疗 12 个月后将美容效果评为 "非常好 "或 "好"。在随访期间，皮肤质量的所有参数都得到了进一步改善：我们的研究结果表明，使用 BF-200 ALA 和窄谱红光进行场导向光导治疗的效果在随访期间得以保持。根据我们的研究结果，场导向光导疗法是一种对 AK 患者有益的长效治疗方法：临床试验注册号：2013-002510-12（EudraCT）；NCT01966120（Clinicaltrials.gov）。
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.
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