Infrared Bioeffect System for the Treatment of Onychomycosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperthermia

Intervention / Treatment
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* Device: infrared thermotherapy instrument


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Local hyperthermia for the Treatment of Onychomycosis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Hyperthermia for the Treatment of Onychomycosis<br>(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<br>* Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermia, onychomycosis