Itraconazole pills, local infrared heat, or both for sporotrichosis
A Randomized Controlled Clinical Trial of Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
This trial will test whether taking itraconazole, applying local infrared heat, or combining both helps people with sporotrichosis clear their infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT06300138 on ClinicalTrials.gov |
What this trial studies
Participants receive one of three approaches: oral itraconazole, localized infrared thermotherapy, or the combination of both, with clinical follow-up to track lesion healing and microbiological clearance. The protocol builds on prior observations that local hyperthermia can speed lesion resolution and may shift macrophages from an anti-inflammatory M2 state to a pro-inflammatory M1 state. Laboratory work suggests heat triggers CRAC calcium channels and increases NLRP3 inflammasome signaling in macrophages, which could enhance fungal killing. The clinical arm tests whether the physiological effects of heat translate into better outcomes alone or when added to standard antifungal therapy.
Who should consider this trial
Good fit: Adults with pathology- and culture-confirmed sporotrichosis who can give informed consent and can cooperate with treatment visits (and who do not have recent antifungal therapy or HIV infection) are eligible.
Not a fit: People with uncontrolled immunodeficiency (including HIV), recent systemic or local antifungal treatment, allergy to itraconazole, or inability to maintain a stable posture for thermotherapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approaches could shorten treatment time or improve cure rates and offer a noninvasive local therapy option for some patients.
How similar studies have performed: Previous reports have shown local hyperthermia can be effective for sporotrichosis and can activate macrophage CRAC channels, but combining thermotherapy with antifungal drugs has been less well studied in clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenyang
- First Hospital of China Medical University — Shenyang, China (Recruiting)
Study contacts
- Study coordinator: Zhengxiu Li, Doctor
- Email: lizx_cmu@foxmail.com
- Phone: 024-83282524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.