NCT06300138 Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
| NCT ID | NCT06300138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Hospital of China Medical University |
| Condition | Sporotrichosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-03-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06300138 clinical trial?
This trial is open to participants of all sexes, studying Sporotrichosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06300138 currently recruiting?
Yes, NCT06300138 is actively recruiting participants. Contact the research team at lizx_cmu@foxmail.com for enrollment information.
Where is the NCT06300138 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06300138 clinical trial?
NCT06300138 is sponsored by First Hospital of China Medical University. The trial plans to enroll 150 participants.