Infrared Bioeffect System for the Treatment of Onychomycosis

September 12, 2023 updated by: Gao Xinghua

A Multicenter Clinical Trial of Infrared Bioeffect System for the Treatment of Onychomycosis

Onychomycosis is a common nail plate infection caused by dermatophytes, non-dermatophytic molds, and yeasts. The disease is difficult to achieve self-healing and predisposed to secondary bacterial infections. There are currently multiple medications that can be used for the treatment of onychomycosis. The limitations are high recurrence rate and high cost, time-consuming and drug interactions. Several FDA approved laser devices have been available for the treatment of onychomycosis since 2010. As an emerging physical therapy modality, laser and light have advantages including extensive applicable range, simple operation, less trauma, and it will not lead to generation of new resistant strains. Therefore, it has been popularized and applied in clinics, especially among elderly, immunocompromised patients, or those with liver and kidney dysfunction. Laser systems in the near-infrared spectrum (780 nm∼ 3,000 nm wavelength), which are commonly used in onychomycosis, exert their effect by direct heating of target tissues, but it can cause unbearable physical pain to the patient. Compared with laser, controllable infrared bioeffect system has the advantages of high safety, less trauma, and less pain. Reported in the literature, it has been observed that regression of distant, untreated skin lesions in patients treated locally with controllable infrared bioeffect system, especially in inflammatory skin diseases such as viral warts and sporotrichosis. The aim of the research is to evaluate the safety and efficacy of controllable infrared bioeffect system in treatment of onychomycosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mild local hyperthermia with a certain temperature range has been successfully used in treatment of some diseases. It has been applied in the treatment of some neoplasm, fungal and HPV infections. Previous studies regarding viral warts and sporotrichosis found that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate pathogenic microorganisms. Investigators speculate that mild local hyperthermia was a potential treatment for onychomycosis. A prospective single arm clinical trial was conducted to evaluate the effectiveness and safety of mild local hyperthermia in the treatment of onychomycosis. Participants with onychomycosis with at least 2 nails involved were included. The treatment effect of the treated and the untreated nail onychomycosis was measured after 6 months and 12 months of initial treatment.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:

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

Yes

Description

Inclusion Criteria:

  1. Male and female patients between 18 and 70 years old.
  2. Patients with Onychomycosis confirmed by clinic and microscopic examination or culture of fungi.
  3. All subjects voluntarily joined this study with informed consents.
  4. The subjects have good compliance and can cooperate with investigators follow-up study.

Exclusion Criteria:

  1. The patients during the period of pregnancy or breastfeeding.
  2. The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively.
  3. Patients who suffered from progressive disease, autoimmune, tumor diseases or other diseases adjudged by the investigator to be inappropriate for inclusion into the study.
  4. Other conditions adjudged by the investigator to be inappropriate for inclusion into the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local Hyperthermia for the Treatment of Onychomycosis
(1) In months 0-2, local hyperthermia treatment was given once a week for 20 minutes each time, for a total of 9 times; (2) In months 2-4, at the same target lesion, once every 2 weeks, for a total of 4 times; (3) In months 4-6, once every 4 weeks, for a total of 2 times. The frequency of this course of treatment was 15 times lasting for 6 months, and follow-up ended 12 months from the first treatment.
Device: infrared thermotherapy instrument
Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate of the target nail
Time Frame: 6 months, 9 months and 12 months after the first treatment
Clinical and mycological cure rate of the target nail at 6 months, 9 months and12 months after the first treatment
6 months, 9 months and 12 months after the first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate of non-targeted nail
Time Frame: 6 months, 9 months, 12 months after the first treatment
Clinical and mycological cure rate of non-target nail at 6 months, 9 months and12 months after the first treatment
6 months, 9 months, 12 months after the first treatment

Collaborators and Investigators

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

Sponsor

Gao Xinghua

Collaborators

Jining Medical University
Binzhou Medical University

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 (Actual)

February 24, 2023

Primary Completion (Estimated)

February 24, 2024

Study Completion (Estimated)

August 24, 2024

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH20230410

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

No

Studies a U.S. FDA-regulated device product

No

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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