Clinical trial NCT06300138: Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
Official title: A Randomized Controlled Clinical Trial of Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sporotrichosis
Keywords: Sporotrichosis
local hyperthermia
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the overall clinical clearance rate of skin lesions
timeFrame: Three months
Secondary outcomes:
measure: Overall clinical clearance rate and recurrence rate
timeFrame: Six months
measure: adverse reactions and incidence
timeFrame: Six months
measure: the clearance rate of target skin lesions
timeFrame: Three months
measure: overall lesion clearance rate
timeFrame: Three months
Other outcomes:
Locations:
Study officials:
References: