Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-31

Brief Summary

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The main objective of this study is to compare the efficacy of treatment of onychomycosis by: diode laser combined with photodynamic therapy, and topical treatment with Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.

The study is a low-intervention, randomised controlled clinical trial. Patient recruitment will be done by including in the sample those patients who have diagnostic confirmation of onychomycosis in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid. Participants in the trial will be assigned with equal probability to each treatment arm, according to their consecutive inclusion in the study. Subsequently, treatment assignment will be determined by a random code. The treatment used will be evident to both the participant and the podiatrist responsible for the intervention.

Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.

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Detailed Description

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Visits will be made every 7 days at the start of treatment and for 9 weeks in group 1 (treatment with laser and photodynamic therapy), and monthly visits in group 2 (treatment with ciclopirox nail polish) during the 12 months of follow-up. Regardless of the follow-up week at which healing occurs, all patients will be reviewed at 3, 6, 9 and 12 months after the first visit.

Conditions

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Onychomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)

According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.

Group Type EXPERIMENTAL

Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®

Intervention Type DEVICE

According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.

Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.

Group Type ACTIVE_COMPARATOR

Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

Intervention Type DRUG

The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.

Interventions

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Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®

According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.

Intervention Type DEVICE

Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.

Intervention Type DRUG

Other Intervention Names

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Laser Control

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with toenail onychomycosis with positive microbiological culture/PCR.
* Patients over 18 years of age.

Exclusion Criteria

* Patients who have received topical or systemic antifungal treatment in the previous month.
* Pregnancy or lactation.
* Patients with peripheral vascular disease.
* Patients with an immune system disorder or undergoing treatment with immunosuppressants.
* Patients with peripheral or central neuropathy.
* Patients with a coagulation disorder.
* Patients with Raynaud's disease or with any alteration in the perception of cold or heat.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No