Infrared Bioeffect System for the Treatment of Onychomycosis
Hyperthermia
About this trial
This is an interventional treatment trial for Hyperthermia focused on measuring hyperthermia, onychomycosis
Eligibility Criteria
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 The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively.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.
Sites / Locations
- The First Affiliated Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
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.