NCT05809297

Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®	According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
DRUG	Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer	The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-04-01
• Completion: 2024-12-31
• First posted: 2023-04-12
• Last updated: 2023-05-10

Regulatory

• FDA-regulated drug study
• FDA-regulated device study