Clinical trial NCT05809297: Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
Official title: Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Onychomycosis
Keywords: onychomycosis
laser
ciclopirox
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
timeFrame: 12 months
measure: Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
timeFrame: 12 months
measure: Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: To analyse the influence of the type of onychomycosis on the response to treatment.
timeFrame: 12 months
measure: To analyse the influence of the causal fungal agent on the response to treatment.
timeFrame: 12 months
measure: To analyse the influence of the degree of severity of onychomycosis on the response to treatment.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Francisco Javier Álvaro Afonso
role: PRINCIPAL_INVESTIGATOR
References: