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

Primary Purpose

Onychomycosis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®
Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring onychomycosis, laser, ciclopirox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)

    Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer

    Arm Description

    According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.

    The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.

    Outcomes

    Primary Outcome Measures

    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Clinical cure (yes/no).
    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Mycological cure (yes/no)
    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Complete cure (yes/no)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    May 9, 2023
    Sponsor
    Universidad Complutense de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05809297
    Brief Title
    Diode Laser and Photodynamic Therapy Vs. Ciclopirox.
    Acronym
    Laser
    Official Title
    Diode Laser and Photodynamic Therapy Versus Ciclopirox Hydroxypropyl Chitosan. Randomised Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Onychomycosis
    Keywords
    onychomycosis, laser, ciclopirox

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo® (MEDENCY)
    Arm Type
    Experimental
    Arm Description
    According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
    Arm Title
    Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
    Arm Type
    Active Comparator
    Arm Description
    The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.
    Intervention Type
    Device
    Intervention Name(s)
    Diode laser combined with photodynamic-red laser therapy by RapidoPodia Laser Diodo®
    Other Intervention Name(s)
    Laser
    Intervention Description
    According to the manufacturer's recommendations, the treatment will be carried out in consultation in 8 sessions by a specialised podiatrist.
    Intervention Type
    Drug
    Intervention Name(s)
    Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer
    Other Intervention Name(s)
    Control
    Intervention Description
    The application of Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer will be performed at home by the patient once a day.
    Primary Outcome Measure Information:
    Title
    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Description
    Clinical cure (yes/no).
    Time Frame
    12 months
    Title
    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Description
    Mycological cure (yes/no)
    Time Frame
    12 months
    Title
    Efficacy of treatment of onychomycosis with diode laser combined with photodynamic therapy versus Ciclopirox Hydroxypropyl Chitosan (HPCH) Nail Lacquer.
    Description
    Complete cure (yes/no)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    Clinical cure (yes/no)
    Time Frame
    12 months
    Title
    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.
    Description
    Mycological cure (yes/no).
    Time Frame
    12 months
    Title
    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.
    Description
    Complete cure (yes/no).
    Time Frame
    12 months
    Title
    To analyse the influence of the type of onychomycosis on the response to treatment.
    Description
    Onychomycosis clasification (ODL, total dystrophic, superficial)
    Time Frame
    12 months
    Title
    To analyse the influence of the causal fungal agent on the response to treatment.
    Description
    Causal fungal agent (dermatophyte, mould or yeast)
    Time Frame
    12 months
    Title
    To analyse the influence of the degree of severity of onychomycosis on the response to treatment.
    Description
    Onychomycosis severity index (OSI)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francisco Javier Álvaro Afonso, PhD
    Phone
    91 394 1535
    Email
    alvaro@ucm.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francisco Javier Álvaro Afonso, PhD
    Phone
    91 394 1535
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco Javier Álvaro Afonso
    Organizational Affiliation
    Universidad Complutense de Madrid
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Diode Laser and Photodynamic Therapy Vs. Ciclopirox.

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