Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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.