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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY) | Experimental | 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 | Active Comparator | The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® | Device | According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Javier Álvaro Afonso, PhD | Contact | 91 394 1535 | alvaro@ucm.es | |
| Francisco Javier Álvaro Afonso, PhD | Contact | 91 394 1535 |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier Álvaro Afonso | Universidad Complutense de Madrid | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41024682 | Derived | Garcia-Oreja S, Alvaro-Afonso FJ, Navarro-Perez D, Leon-Herce D, Tardaguila-Garcia A, Lazaro-Martinez JL. Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial. Mycoses. 2025 Oct;68(10):e70121. doi: 10.1111/myc.70121. |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
| Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer | Drug | The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day. |
|
|
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 |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |