The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Infrared Bioeffect System for the Treatment of Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06036654
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Collaborators:
Jining Medical University
Binzhou Medical University
Information provided by (Responsible Party):
Gao Xinghua, First Hospital of China Medical University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hyperthermia Device: infrared thermotherapy instrument Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Local hyperthermia for the Treatment of Onychomycosis
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Trial of Infrared Bioeffect System for the Treatment of Onychomycosis
Actual Study Start Date : February 24, 2023
Estimated Primary Completion Date : February 24, 2024
Estimated Study Completion Date : August 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036654


Contacts
Layout table for location contacts
Contact: Xinghua Gao, PhD +86 13940152467 gaobarry@hotmail.com

Locations
Layout table for location information
China, Liaoning
The First Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Rui qun Qi, Doctor    18204027799    xiaoqiliumin@163.com   
Sponsors and Collaborators
Gao Xinghua
Jining Medical University
Binzhou Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gao Xinghua, Vice President, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT06036654    
Other Study ID Numbers: HH20230410
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gao Xinghua, First Hospital of China Medical University:
hyperthermia
onychomycosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Onychomycosis
Hyperthermia
Fever
Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries