Diode Laser and Photodynamic Therapy Vs. Ciclopirox. (Laser)

May 9, 2023 updated by: FRANCISCO JAVIER ALVARO AFONSO, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francisco Javier Álvaro Afonso, PhD
  • Phone Number: 91 394 1535
  • Email: alvaro@ucm.es

Study Contact Backup

  • Name: Francisco Javier Álvaro Afonso, PhD
  • Phone Number: 91 394 1535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)
According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
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.
Other Names:
  • Laser
Active Comparator: 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.
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.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time Frame: 12 months
Clinical cure (yes/no).
12 months
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time Frame: 12 months
Mycological cure (yes/no)
12 months
Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
Time Frame: 12 months
Complete cure (yes/no)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Clinical cure (yes/no)
12 months
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.
Time Frame: 12 months
Mycological cure (yes/no).
12 months
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.
Time Frame: 12 months
Complete cure (yes/no).
12 months
To analyse the influence of the type of onychomycosis on the response to treatment.
Time Frame: 12 months
Onychomycosis clasification (ODL, total dystrophic, superficial)
12 months
To analyse the influence of the causal fungal agent on the response to treatment.
Time Frame: 12 months
Causal fungal agent (dermatophyte, mould or yeast)
12 months
To analyse the influence of the degree of severity of onychomycosis on the response to treatment.
Time Frame: 12 months
Onychomycosis severity index (OSI)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Francisco Javier Álvaro Afonso, Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nº EudraCT 2022-003913-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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