Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

Study Overview
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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.

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.

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

Conditions
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Onychomycosis

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)<br>According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist. | Device: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®<br>* According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.<br>* Other names: Laser;|
| Active Comparator: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer<br>The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. | Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer<br>* The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer. | Clinical cure (yes/no). | 12 months | 
| Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer. | Mycological cure (yes/no) | 12 months | 
| Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer. | Complete cure (yes/no) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve clinical cure of onychomycosis. | Clinical cure (yes/no) | 12 months | 
| To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve, mycological cure of onychomycosis. | Mycological cure (yes/no). | 12 months | 
| To determine whether 8 sessions of diode laser treatment combined with photodynamic therapy, at different wavelengths, over a period of nine weeks, is sufficient to achieve complete cure of onychomycosis. | Complete cure (yes/no). | 12 months | 
| To analyse the influence of the type of onychomycosis on the response to treatment. | Onychomycosis clasification (ODL, total dystrophic, superficial) | 12 months | 
| To analyse the influence of the causal fungal agent on the response to treatment. | Causal fungal agent (dermatophyte, mould or yeast) | 12 months | 
| To analyse the influence of the degree of severity of onychomycosis on the response to treatment. | Onychomycosis severity index (OSI) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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onychomycosis, laser, ciclopirox