Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

Universidad Complutense de Madrid

Status and phase: Not yet enrolling; Phase 4

Conditions: Onychomycosis

Treatments: Device: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®; Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

Study type: Interventional

Funder types: Other

Identifiers

NCT05809297

Nº EudraCT 2022-003913-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

Active Comparator group

Description:

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

Treatment:

Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer