NCT06036654

Infrared Bioeffect System for the Treatment of Onychomycosis

Status unknown NA Last updated 14 September 2023

What this trial tests

NA trial testing infrared thermotherapy instrument in Hyperthermia in 60 participants. Status unknown.

Timeline

24 February 2023

Primary endpoint
24 February 2024

24 August 2024

Quick facts

Lead sponsor	Gao Xinghua
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	24 February 2023
Primary completion	24 February 2024
Estimated completion	24 August 2024
Sites	1 location across China

Drugs / interventions tested

• infrared thermotherapy instrument

Conditions studied

• Hyperthermia — all drugs for Hyperthermia →

Sponsor

Gao Xinghua

Who can join

Adults 18 to 70, any sex, with Hyperthermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.