Infrared Bioeffect System for the Treatment of Onychomycosis

Hyperthermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036654
• Other study ID #: HH20230410
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: August 24, 2024

Study information

• Verified date: September 2023
• Source: First Hospital of China Medical University
• Contact: Xinghua Gao, PhD
• Phone: +86 13940152467
• Email: gaobarry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 24, 2024
• Est. primary completion date: February 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Onychomycosis

Intervention

Device:
• infrared thermotherapy instrument
Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (3)

Lead Sponsor	Collaborator
Gao Xinghua	Binzhou Medical University, Jining Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months, 9 months and 12 months after the first treatment
Secondary	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	6 months, 9 months, 12 months after the first treatment