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

Sporotrichosis Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300138
• Other study ID #: 2023-631-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: First Hospital of China Medical University
• Contact: Zhengxiu Li, Doctor
• Phone: 024-83282524
• Email: lizx_cmu[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Sporotrichosis

Intervention

Drug:
• 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

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall clinical clearance rate and recurrence rate	Overall clinical clearance rate and recurrence rate of skin lesions in three groups	Six months
Secondary	adverse reactions and incidence	adverse reactions and incidence in three groups	Six months
Secondary	the clearance rate of target skin lesions	Three months after treatment, the clearance rate of target skin lesions in hyperthermia treatment group and hyperthermia combined with antifungal therapy group.	Three months
Secondary	overall lesion clearance rate	In patients with multiple lesions, the overall lesion clearance rate was 3 months after treatment.	Three months