NCT06036654

Infrared Bioeffect System for the Treatment of Onychomycosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gao Xinghua · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperthermia

Interventions

Type	Name	Description
DEVICE	infrared thermotherapy instrument	Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.

Timeline

• Start date: 2023-02-24
• Primary completion: 2024-02-24
• Completion: 2024-08-24
• First posted: 2023-09-14
• Last updated: 2023-09-14

Locations

1 site across 1 country: China