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Infrared Bioeffect System for the Treatment of Onychomycosis

Primary Purpose

Hyperthermia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infrared thermotherapy instrument
Sponsored by
Gao Xinghua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperthermia focused on measuring hyperthermia, onychomycosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female patients between 18 and 70 years old. Patients with Onychomycosis confirmed by clinic and microscopic examination or culture of fungi. All subjects voluntarily joined this study with informed consents. The subjects have good compliance and can cooperate with investigators follow-up study. Exclusion Criteria: The patients during the period of pregnancy or breastfeeding. The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively. Patients who suffered from progressive disease, autoimmune, tumor diseases or other diseases adjudged by the investigator to be inappropriate for inclusion into the study. Other conditions adjudged by the investigator to be inappropriate for inclusion into the study.

Sites / Locations

  • The First Affiliated Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Local Hyperthermia for the Treatment of Onychomycosis

Arm Description

(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.

Outcomes

Primary Outcome Measures

Cure rate of the target nail
Clinical and mycological cure rate of the target nail at 6 months, 9 months and12 months after the first treatment

Secondary Outcome Measures

Cure rate of non-targeted nail
Clinical and mycological cure rate of non-target nail at 6 months, 9 months and12 months after the first treatment

Full Information

First Posted
August 24, 2023
Last Updated
September 12, 2023
Sponsor
Gao Xinghua
Collaborators
Jining Medical University, Binzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06036654
Brief Title
Infrared Bioeffect System for the Treatment of Onychomycosis
Official Title
A Multicenter Clinical Trial of Infrared Bioeffect System for the Treatment of Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
February 24, 2024 (Anticipated)
Study Completion Date
August 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gao Xinghua
Collaborators
Jining Medical University, Binzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia
Keywords
hyperthermia, onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Local hyperthermia for the Treatment of Onychomycosis
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local Hyperthermia for the Treatment of Onychomycosis
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Device
Intervention Name(s)
infrared thermotherapy instrument
Intervention Description
Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.
Primary Outcome Measure Information:
Title
Cure rate of the target nail
Description
Clinical and mycological cure rate of the target nail at 6 months, 9 months and12 months after the first treatment
Time Frame
6 months, 9 months and 12 months after the first treatment
Secondary Outcome Measure Information:
Title
Cure rate of non-targeted nail
Description
Clinical and mycological cure rate of non-target nail at 6 months, 9 months and12 months after the first treatment
Time Frame
6 months, 9 months, 12 months after the first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female patients between 18 and 70 years old. Patients with Onychomycosis confirmed by clinic and microscopic examination or culture of fungi. All subjects voluntarily joined this study with informed consents. The subjects have good compliance and can cooperate with investigators follow-up study. Exclusion Criteria: The patients during the period of pregnancy or breastfeeding. The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively. Patients who suffered from progressive disease, autoimmune, tumor diseases or other diseases adjudged by the investigator to be inappropriate for inclusion into the study. Other conditions adjudged by the investigator to be inappropriate for inclusion into the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Gao, PhD
Phone
+86 13940152467
Email
gaobarry@hotmail.com
Facility Information:
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui qun Qi, Doctor
Phone
18204027799
Email
xiaoqiliumin@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Infrared Bioeffect System for the Treatment of Onychomycosis

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