NCT05809297

Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
Universidad Complutense de Madrid·Phase 4·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Onychomycosis
Drug/Device/Intervention
Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Universidad Complutense de Madrid
Timeline & enrollment
Phase
Phase 4
Start date
Sep 01, 2023
End date
Dec 31, 2024
Enrollment
26 participants
Primary outcome

Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.,Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.,Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.

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.

ICD-10 classifications
OnychogryphosisChromomycosis, unspecifiedOnycholysisActinomycosisBlastomycosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05809297
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05809297 through Pure Global AI's free database. This Phase 4 trial is sponsored by Universidad Complutense de Madrid and is currently Not yet recruiting. The study focuses on Onychomycosis. Target enrollment is 26 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.