Diode Laser and Photodynamic Therapy Vs. Ciclopirox. - Trial NCT05809297
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.
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Study Focus
Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®
Interventional
device
Sponsor & Location
Universidad Complutense de Madrid
Timeline & Enrollment
Phase 4
Sep 01, 2023
Dec 31, 2024
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
Data Source
ClinicalTrials.gov
NCT05809297
Device Trial