SporotrichosisNCT06300138
Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
A study testing Itraconazole, Infrared thermotherapy apparatus and Itraconazole and Infrared thermotherapy apparatus in people with Sporotrichosis, run by First Hospital of China Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sporotrichosis
- What is being tested?
- Itraconazole, Infrared thermotherapy apparatus and Itraconazole and Infrared thermotherapy apparatus
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of China Medical University
Shenyang
About this study
Official title: A Randomized Controlled Clinical Trial of Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
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
- Being tested
- Itraconazole, Infrared thermotherapy apparatus, Itraconazole and Infrared thermotherapy apparatus
- Keywords
- Sporotrichosis, local hyperthermia
- Medical subject headings
- Sporotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
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
Infrared thermotherapy apparatusDevice
Also called YY-WRY-V01 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.
Itraconazole and Infrared thermotherapy apparatusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Infrared thermotherapy apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall clinical clearance rate of skin lesions
Three months after treatment, the overall clinical clearance rate of skin lesions in the three groups.
Measured: Three months
Secondary outcomes (4)
Overall clinical clearance rate and recurrence rate
Overall clinical clearance rate and recurrence rate of skin lesions in three groups
Measured: Six months
adverse reactions and incidence
adverse reactions and incidence in three groups
Measured: Six months
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.
Measured: Three months
overall lesion clearance rate
In patients with multiple lesions, the overall lesion clearance rate was 3 months after treatment.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SporotrichosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300138
- Sponsor's protocol ID
- 2023-631-2
- Status last verified
- Mar 2026
- First submitted
- 29 Feb 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Antifungal Agents and Infrared Thermotherapy Alone or in Combination in the Treatment of Sporotrichosis
- ClinicalTrials.gov ID
- NCT06300138
- Acronym / sponsor ID
- 2023-631-2
- Conditions
- Sporotrichosis
- Keywords
- Sporotrichosis, local hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug combined with infrared hyperthermia group | Experimental | Other: Itraconazole and Infrared thermotherapy apparatusoral 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 group | Experimental | Drug: ItraconazoleItraconazole (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. |
| Infrared hyperthermia group | Experimental | Device: Infrared thermotherapy apparatusInfrared 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazoleoral 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 | Drug group |
| Infrared thermotherapy apparatusAlso: YY-WRY-V01 Infrared thermotherapy apparatusinfrared 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 hyperthermia group |
| Itraconazole and Infrared thermotherapy apparatusoral 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 | Drug combined with infrared hyperthermia group |
Primary outcome
the overall clinical clearance rate of skin lesions
Time frame: Three months
Three months after treatment, the overall clinical clearance rate of skin lesions in the three groups.
4 secondary outcomes
Overall clinical clearance rate and recurrence rate
Time frame: Six months
adverse reactions and incidence
Time frame: Six months
the clearance rate of target skin lesions
Time frame: Three months
overall lesion clearance rate
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itraconazole, Infrared thermotherapy apparatus and Itraconazole and Infrared thermotherapy apparatus in people with Sporotrichosis, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengxiu Li, Doctor (024-83282524, lizx_cmu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the overall clinical clearance rate of skin lesions (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.