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

NCT06300138 | Recruiting

• 1 other identifier: 2023-631-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Sporotrichosis; local hyperthermia

Outcome Measures

Primary Outcomes (1)

• the overall clinical clearance rate of skin lesions

  Three months after treatment, the overall clinical clearance rate of skin lesions in the three groups.

  Three months

Secondary Outcomes (4)

• Overall clinical clearance rate and recurrence rate

  Six months

• adverse reactions and incidence

  Six months

• the clearance rate of target skin lesions

  Three months

• overall lesion clearance rate

  Three months

Study Arms (3)

Drug combined with infrared hyperthermia group

EXPERIMENTAL

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.

Other: Itraconazole and Infrared thermotherapy apparatus

Drug group

EXPERIMENTAL

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.

Drug: Itraconazole

Infrared hyperthermia group

EXPERIMENTAL

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.

Device: Infrared thermotherapy apparatus

Interventions

Itraconazole 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

Drug group

Infrared thermotherapy apparatus 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.

Also known as: YY-WRY-V01 Infrared thermotherapy apparatus

Infrared hyperthermia group

Itraconazole and Infrared thermotherapy apparatus 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 combined with infrared hyperthermia group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Sporotrichosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Zhengxiu Li, Doctor

CONTACT

024-83282524; lizx_cmu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)