Infrared Bioeffect System for the Treatment of Onychomycosis

• ClinicalTrials.gov Identifier: NCT06036654
• Recruitment Status: Recruiting
• First Posted: September 14, 2023
• Last Update Posted: September 14, 2023
• Sponsor: Gao Xinghua
• Collaborators: Jining Medical University; Binzhou Medical University
• Information provided by (Responsible Party): Gao Xinghua, First Hospital of China Medical University

Tracking Information

• First Submitted Date: August 24, 2023
• First Posted Date: September 14, 2023
• Last Update Posted Date: September 14, 2023
• Actual Study Start Date: February 24, 2023
• Estimated Primary Completion Date: February 24, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 12, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Hyperthermia

Intervention

Device: infrared thermotherapy instrument

Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.

Study Arms

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.

Intervention: Device: infrared thermotherapy instrument

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 12, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 24, 2024
• Estimated Primary Completion Date: February 24, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Xinghua Gao, PhD; +86 13940152467; gaobarry@hotmail.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06036654
• Other Study ID Numbers: HH20230410
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gao Xinghua, First Hospital of China Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Gao Xinghua
• Original Study Sponsor: Same as current

Collaborators

• Jining Medical University
• Binzhou Medical University

• Investigators: Not Provided
• PRS Account: First Hospital of China Medical University
• Verification Date: September 2023