Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis

NCT ID: NCT06300138

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-12-31

Brief Summary

Sporotrichosis is a chronic granulomatous mycosis caused by sporothrix complex. The course of sporotrichosis is always prolonged and even life-threatening, the treatment of this disease in an important scientific problem to be solved. The investigators previously found the predominance of subtype M2 macrophage which play an anti-inflammatory role in the lesions of sporotrichosis, the predominance of M2 macrophage may be responsible for the persistence of sporotrichosis; the investigators also found that local hyperthermia is effective in the treatment of sporotrichosis and hyperthermia treatment can activate the CRAC calcium channel in macrophages which triggers pro-inflammatory type M1 polarization and subsequent killing of sporothrix, however, the mechanism still calls for further investigation. The investigators hypothesize that hyperthermia leads to the activation of CRAC channels resulting in profound Ca2+ influx and Ca2+ upregulates NLRP3 inflammasome expression through inducing Nrf2 activation, then NLRP3 overexpression triggers M1 polarization and subsequent killing of sporothrix. Furthermore, the activation of Nrf2 upregulates STIM1 expression which forms a positive feedback for M1 type polarization of macrophages and further subsequent killing of sporothrix. The purpose of this project is to identify the hypothesis that hyperthermia could treat sporotrichosis by promoting pro-inflammatory type M1 polarization in macrophages, the mechanism by which hyperthermia could treat sporotrichosis is local hyperthermia could led to STIM1/CRAC calcium channel activation mediated calcium ions/Nrf2/NLRP3 induced M1 macrophages polarization and subsequent killing of sporothrix. The hypothesis will be identified at the cellular level, at the animal model level and at the clinical specimens level. The investigators believe that the project will guide the application of hyperthermia in the treatment of sporotrichosis and provide a new basis of theory and practice after the investigators achieving these goals.

Conditions

Sporotrichosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug combined with infrared hyperthermia group

oral itraconazole (children less than 15 years old 6 mg/kg/d; adult patients: 200 mg/d) for a total course of 3-6 months, while infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Group Type: EXPERIMENTAL

Itraconazole and Infrared thermotherapy apparatus

Intervention Type: OTHER

oral itraconazole (children less than 15 years old 6 mg/kg/d; adult patients: 200 mg/d) for a total course of 3-6 months, while infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Drug group

Itraconazole (6 mg/kg/d; for children less than 15 years old, 200 mg/d for adults) was taken orally for 3-6 months. The specific course of treatment was determined by the research physician according to the recovery of the subjects.

Group Type: EXPERIMENTAL

Itraconazole

Intervention Type: DRUG

oral itraconazole (children less than 15 years old 6 mg/kg/d; adult patients: 200 mg/d) for a total course of 3-6 months

Infrared hyperthermia group

Infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Group Type: EXPERIMENTAL

Infrared thermotherapy apparatus

Intervention Type: DEVICE

infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Interventions

Itraconazole

oral itraconazole (children less than 15 years old 6 mg/kg/d; adult patients: 200 mg/d) for a total course of 3-6 months

Intervention Type: DRUG

Infrared thermotherapy apparatus

infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Intervention Type: DEVICE

Itraconazole and Infrared thermotherapy apparatus

oral itraconazole (children less than 15 years old 6 mg/kg/d; adult patients: 200 mg/d) for a total course of 3-6 months, while infrared hyperthermia device for 3 consecutive days (times / day), each treatment for 30 minutes After two weeks (14 days), the lesions of the same target were treated continuously for 2 days (times per day), and then once a week for 2 consecutive times, the method was the same as before. After 7 times of treatment, the study physician decided whether to continue treatment n times after 1-2 weeks (n ≥ 0) according to the recovery of the subjects.

Intervention Type: OTHER

Other Intervention Names

YY-WRY-V01 Infrared thermotherapy apparatus

Eligibility Criteria

Inclusion Criteria

• The results of pathology and fungal culture were all patients with sporotrichosis.
• Informed consent to the purpose and content of the study, and follow-up as required
• The physical condition and self-condition can cooperate with the treatment.

Exclusion Criteria

• Subjects who are unable to maintain a relatively stable posture during treatment.
• Those who are sensitive or allergic to this experimental drug.
• Systemic antifungal or KI therapy within 12 months
• Local antifungal therapy within 1 month.
• Previous history of immunodeficiency virus (HIV) infection, or positive HIV antibody in screening period.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Gao Xinghua

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Hospital of China Medical University

Shenyang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengxiu Li, Doctor

Role: CONTACT

lizx_cmu@foxmail.com

024-83282524

Other Identifiers

2023-631-2

Identifier Type: -

Identifier Source: org_study_id