Infrared Bioeffect System for the Treatment of Onychomycosis

NCT06036654 | Unknown

• 1 other identifier: HH20230410
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperthermia

Keywords

hyperthermia; onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cure rate of non-targeted nail

  6 months, 9 months, 12 months after the first treatment

Study Arms (1)

Local Hyperthermia for the Treatment of Onychomycosis

EXPERIMENTAL

(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

Interventions

infrared thermotherapy instrument DEVICE

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

Local Hyperthermia for the Treatment of Onychomycosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gao Xinghua: lead
• Jining Medical University: collaborator
• Binzhou Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Hyperthermia; Onychomycosis

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xinghua Gao, PhD

CONTACT

+86 13940152467; gaobarry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President

Model Details: Local hyperthermia for the Treatment of Onychomycosis

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 14, 2023
• Study Start: February 24, 2023
• Primary Completion: February 24, 2024
• Study Completion: August 24, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)