Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

NCT05809297 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: Nº EudraCT 2022-003913-12
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Onychomycosis

Keywords

onychomycosis; laser; ciclopirox

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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.

  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.

  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.

  12 months

• To analyse the influence of the type of onychomycosis on the response to treatment.

  12 months

• To analyse the influence of the causal fungal agent on the response to treatment.

  12 months

Study Arms (2)

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.

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

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.

Drug: Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

Interventions

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.

Also known as: Laser

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

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.

Also known as: Control

Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Related Publications (1)

• 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.

  PMID: 41024682 DERIVED

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Francisco Javier Álvaro Afonso

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Javier Álvaro Afonso, PhD

CONTACT

91 394 1535; alvaro@ucm.es

Francisco Javier Álvaro Afonso, PhD

CONTACT

91 394 1535

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 12, 2023
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share