Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial.

IF 3.1 2区医学 Q1 DERMATOLOGY

Mycoses Pub Date : 2025-10-01 DOI:10.1111/myc.70121

Sara García-Oreja, Francisco Javier Álvaro-Afonso, David Navarro-Pérez, Diego León-Herce, Aroa Tardáguila-García, José Luis Lázaro-Martínez

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引用次数: 0

Abstract

Background: Antifungals are the standard treatment for onychomycosis. However, oral antifungals present contraindications and potential drug-drug interactions, while topical antifungals suffer from limited efficacy and penetration. Recently, researchers have explored physical therapies, including laser and photodynamic therapy.

Objective: To evaluate the clinical efficacy of combining diode laser therapy with photodynamic therapy and ciclopirox 8% hydroxypropyl chitosan (HPCH) nail lacquer in treating onychomycosis.

Methods: We conducted a randomised controlled clinical trial involving patients with onychomycosis. A total of 26 patients were enrolled and followed for 12 months. Participants received either eight sessions of laser treatment combined with three sessions of photodynamic therapy, or daily treatment with ciclopirox 8% HPCH.

Results: The clinical cure rate was 94.1% in the group treated with laser and photodynamic therapy, compared to 53.3% in the group treated with ciclopirox 8% HPCH (p = 0.008). All patients who achieved clinical cure with either treatment also reached mycologic and complete cure, with a rate of 100%. The average time to healing was significantly shorter for the group receiving laser and photodynamic therapy (3.6 ± 1.2 months) than for those treated with ciclopirox 8% HPCH nail lacquer (9.2 ± 1.6 months) (p < 0.001). In the laser and photodynamic therapy group, adverse events, specifically subungual hematoma and blisters, occurred in 11.4% of patients, with a recurrence rate of 33.3%. No adverse events or recurrence were observed in patients treated with ciclopirox 8% HPCH.

Conclusions: Treatment of onychomycosis using diode laser and photodynamic therapy results in higher clinical cure rates and shorter healing times compared to the reference treatment with 8% ciclopirox HPCH.

Trial registration: ClinicalTrials.gov identifier: NCT05809297.

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二极管激光和红色激光光动力疗法与环匹洛克斯8% HPCH甲漆治疗甲真菌病：一项随机对照试验。

背景：抗真菌药物是治疗甲真菌病的标准方法。然而，口服抗真菌药物存在禁忌症和潜在的药物相互作用，而局部抗真菌药物的疗效和渗透性有限。最近，研究人员探索了物理疗法，包括激光和光动力疗法。目的：评价二极管激光联合光动力疗法及环匹罗8%羟丙基壳聚糖（HPCH）甲漆治疗甲癣的临床疗效。方法：我们进行了一项随机对照临床试验，纳入了甲真菌病患者。共有26名患者入组，随访12个月。参与者接受8次激光治疗结合3次光动力治疗，或每日使用环匹罗酮8% HPCH治疗。结果：激光联合光动力治疗组的临床治愈率为94.1%，而环吡醇8% HPCH治疗组的临床治愈率为53.3% （p = 0.008）。两种治疗均达到临床治愈的患者均达到菌丝学完全治愈，治愈率为100%。激光光动力治疗组的平均愈合时间（3.6±1.2个月）明显短于光动力治疗组（9.2±1.6个月）(p)。结论：激光光动力治疗甲癣的临床治愈率和愈合时间明显短于光动力治疗组（8%）。试验注册：ClinicalTrials.gov标识符：NCT05809297。

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

Mycoses 医学-皮肤病学

CiteScore

10.00

自引率

8.20%

发文量

143

审稿时长

6-12 weeks

期刊介绍： The journal Mycoses provides an international forum for original papers in English on the pathogenesis, diagnosis, therapy, prophylaxis, and epidemiology of fungal infectious diseases in humans as well as on the biology of pathogenic fungi. Medical mycology as part of medical microbiology is advancing rapidly. Effective therapeutic strategies are already available in chemotherapy and are being further developed. Their application requires reliable laboratory diagnostic techniques, which, in turn, result from mycological basic research. Opportunistic mycoses vary greatly in their clinical and pathological symptoms, because the underlying disease of a patient at risk decisively determines their symptomatology and progress. The journal Mycoses is therefore of interest to scientists in fundamental mycological research, mycological laboratory diagnosticians and clinicians interested in fungal infections.