Evidence map›Paper›PMID 41024682›Full record

Trial reportMycoses2025

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

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

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Mycoses, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05809297 (Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05809297 phase4unknown statusnot on this map

Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.

TypeinterventionalSponsorUniversidad Complutense de MadridRan2023 to 2024Enrolled26ConditionsOnychomycosisArmsDiode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®, Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Sara García-OrejaUniversity Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.ORCID https://orcid.org/0000-0002-2937-7122
Francisco Javier Álvaro-AfonsoDiabetic Foot Unit, University Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Health Research Institute of the San Carlos Clinical Hospital (IdISSC), Madrid, Spain.ORCID https://orcid.org/0000-0003-4674-3822
David Navarro-PérezUniversity Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.ORCID https://orcid.org/0000-0003-3588-0557
Diego León-HerceUniversity Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Madrid, Spain.ORCID https://orcid.org/0009-0009-7973-9652
Aroa Tardáguila-GarcíaDiabetic Foot Unit, University Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Health Research Institute of the San Carlos Clinical Hospital (IdISSC), Madrid, Spain.ORCID https://orcid.org/0000-0001-5650-7351
José Luis Lázaro-MartínezDiabetic Foot Unit, University Podiatry Clinic, Faculty of Nursing, Physiotherapy and Podiatry, Complutense University of Madrid, Health Research Institute of the San Carlos Clinical Hospital (IdISSC), Madrid, Spain.ORCID https://orcid.org/0000-0001-6110-0265

Funding

Complutense University and Banco Santander
6 · The paper itself

Abstract

backgroundAntifungals 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.

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

methodsWe 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.

resultsThe 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.

conclusionsTreatment 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 registrationClinicalTrials.gov identifier: NCT05809297.

Indexed as

Antifungal AgentsChitosanCiclopiroxLasers, SemiconductorOnychomycosisPhotochemotherapyPyridonesAdultAgedFemaleHumansLacquerMaleMiddle AgedNailsTreatment OutcomeAntifungal AgentsChitosanCiclopiroxPyridonesciclopiroxlaseronychomycosisphotodynamic therapytoluidinetopical antifungaltreatment

Identifiers

PMID41024682
PMCPMC12481177

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.