Refactory WartsNCT07565350
Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts
A study testing An infrared hyperthermia device, Hydrogen Peroxide 3 % Topical Solution and Normal Saline (NS) in people with Refactory Warts, run by First Hospital of China Medical University at 2 sites in China.
Trial summary
1. Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refactory Warts
- What is being tested?
- An infrared hyperthermia device, Hydrogen Peroxide 3 % Topical Solution and Normal Saline (NS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2025to 30 Dec 2027
- 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
- 1: Patients with a disease course of ≥2 years who have failed to respond to ≥2 treatment methods (such as topical ointments, cryotherapy, laser therapy, etc.)
- 2: The subject or their legal guardian is able to understand and sign the informed consent form/agree to participate in the study.
Who cannot join
- 1: The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study
- 2: Individuals allergic to local hyperthermia or hydrogen peroxide;
- 3: Subjects with tumors or other serious diseases are unable to complete this clinical study;
- 4: Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
Shenyang, Liaoning, 110001
+86 13792269768
- Recruiting
Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
Shenyang, Liaoning
About this study
Official title: Randomized Single-blind Parallel Controlled Clinical Trial of Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts
- Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. The clinical challenge in treating refractory viral warts lies in the limited effectiveness of single therapeutic approaches, high recurrence rates, and the fact that a significant proportion of patients are infected with high-risk or special HPV subtypes. These factors necessitate combined multi-modal treatments and genetic etiological screening.
- Current Treatment Status Thermotherapy (44°C ± 2°C, 30 minutes per session): Studies have demonstrated that it can stimulate the activation of local immune cells (such as Langerhans cells), thereby enhancing antiviral immune responses. Hydrogen peroxide: It possesses antibacterial properties and promotes tissue repair. In keratinocytes, it can induce thermally induced pyroptosis, thereby enhancing the efficacy of antiviral treatment.
- HPV genotyping Refractory viral warts are often associated with infection by specific high-risk or low-risk HPV subtypes (e.g., HPV 16, 18, 2, 4, etc.). HPV genotype is closely linked to treatment outcomes and recurrence rates.
- Relevant pathogenic gene screening This involves exploring intrinsic patient susceptibility, such as genetic polymorphisms related to immune function (e.g., HLA typing or Toll-like receptor-related genes). It also includes screening for rare gene mutations, such as mutations in the GATA2, IL2RG, and DOCK8 genes, which lead to impaired viral clearance and a propensity to develop multiple viral warts.
- Conditions
- Refactory Warts
- Being tested
- An infrared hyperthermia device, Hydrogen Peroxide 3 % Topical Solution, Normal Saline (NS)
- Keywords
- Thermotherapy; Hydrogen peroxide; Refractory viral warts
- Medical subject headings
- Hyperthermia, Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An infrared hyperthermia deviceDevice
(Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) An infrared hyperthermia device was used to apply local hyperthermia at 44°C to the target warts(largest and most severe warts).The device includes a heating source, an infrared temperature monitor, an adjusting arm, a control circuit for temperature stabilization, and a display. It uses a tungsten-halogen lamp (wavelength: 760-2300 nm, peak at 1200 nm) to maintain the temperature of a 0.5*0.5 cm skin area within ±0.1°C using a non-contact infrared feedback system.Hyperthermia: Conduct 44-degree Celsius, 30-minute sessions. Do it daily for the first 3 days, then 2 sessions every 7 days for 24 weeks.
Hydrogen Peroxide 3 % Topical SolutionDrug
Dressing: Dress with a cotton ball soaked in 3% hydrogen peroxide one hour prior to each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
Normal Saline (NS)Drug
The control group used normal saline as the placebo for wet compress, and the hyperthermia treatment was the same as that of the trial group.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Local hyperthermia combined with hydrogen peroxide Receives: Device: An infrared hyperthermia device; Drug: Hydrogen Peroxide 3 % Topical Solution |
| Control group | Placebo comparator | Local hyperthermia combined with normal saline Receives: Device: An infrared hyperthermia device; Drug: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance rate of warts within 6 months
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
Measured: 6 months after the first time of treatment.
Recurrence rate of warts
Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
Measured: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.
Complete clearance rate of warts within 3 months
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments.
Measured: 3 months after the first time of treatment.
HPV genotyping
Collect the tissue sample from the wart for HPV gene testing.
Measured: Pre-treatment and 3,6 months after the first time of treatment
Pathogenic Gene Screening Analysis
Collecting patient blood samples for pathogenic gene screening
Measured: Pre-treatment
Immune-related cytokines
Collecting the patient's blood samples to test immune-related cytokines
Measured: Pre-treatment and 3,6 months after the first time of treatment
Secondary outcomes (5)
Changes in the size and number of warts at different points in time
Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks)
Measured: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
Curative effect of different types of warts
The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months.
Measured: followed up at 6 months.
Occurrence of adverse events
occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)
Measured: During treatment and follow-up
Treatment-related pain intensity
Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180)
Patient satisfaction score
Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied)
Measured: At 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refactory WartsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- NCT07565350
- Sponsor's protocol ID
- 2025-641-2
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2026
- Last updated
- 4 May 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single-blind Parallel Controlled Clinical Trial of Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts
- ClinicalTrials.gov ID
- NCT07565350
- Acronym / sponsor ID
- 2025-641-2
- Conditions
- Refactory Warts
- Keywords
- Thermotherapy; Hydrogen peroxide; Refractory viral warts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 May 2026 (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.
- Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. The clinical challenge in treating refractory viral warts lies in the limited effectiveness of single therapeutic approaches, high recurrence rates, and the fact that a significant proportion of patients are infected with high-risk or special HPV subtypes. These factors necessitate combined multi-modal treatments and genetic etiological screening.
- Current Treatment Status Thermotherapy (44°C ± 2°C, 30 minutes per session): Studies have demonstrated that it can stimulate the activation of local immune cells (such as Langerhans cells), thereby enhancing antiviral immune responses. Hydrogen peroxide: It possesses antibacterial properties and promotes tissue repair. In keratinocytes, it can induce thermally induced pyroptosis, thereby enhancing the efficacy of antiviral treatment.
- HPV genotyping Refractory viral warts are often associated with infection by specific high-risk or low-risk HPV subtypes (e.g., HPV 16, 18, 2, 4, etc.). HPV genotype is closely linked to treatment outcomes and recurrence rates.
- Relevant pathogenic gene screening This involves exploring intrinsic patient susceptibility, such as genetic polymorphisms related to immune function (e.g., HLA typing or Toll-like receptor-related genes). It also includes screening for rare gene mutations, such as mutations in the GATA2, IL2RG, and DOCK8 genes, which lead to impaired viral clearance and a propensity to develop multiple viral warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Device: An infrared hyperthermia device, Drug: Hydrogen Peroxide 3 % Topical SolutionLocal hyperthermia combined with hydrogen peroxide |
| Control group | Placebo comparator | Device: An infrared hyperthermia device, Drug: Normal Saline (NS)Local hyperthermia combined with normal saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1: Patients with a disease course of ≥2 years who have failed to respond to ≥2 treatment methods (such as topical ointments, cryotherapy, laser therapy, etc.)
- 2: The subject or their legal guardian is able to understand and sign the informed consent form/agree to participate in the study.
Key exclusion criteria (4 listed)
- 1: The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study
- 2: Individuals allergic to local hyperthermia or hydrogen peroxide;
- 3: Subjects with tumors or other serious diseases are unable to complete this clinical study;
- 4: Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.
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 |
|---|---|---|
| An infrared hyperthermia device(Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) An infrared hyperthermia device was used to apply local hyperthermia at 44°C to the target warts(largest and most severe warts).The device includes a heating source, an infrared temperature monitor, an adjusting arm, a control circuit for temperature stabilization, and a display. It uses a tungsten-halogen lamp (wavelength: 760-2300 nm, peak at 1200 nm) to maintain the temperature of a 0.5*0.5 cm skin area within ±0.1°C using a non-contact infrared feedback system.Hyperthermia: Conduct 44-degree Celsius, 30-minute sessions. Do it daily for the first 3 days, then 2 sessions every 7 days for 24 weeks. | Device | Control group, Trial group |
| Hydrogen Peroxide 3 % Topical SolutionDressing: Dress with a cotton ball soaked in 3% hydrogen peroxide one hour prior to each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. | Drug | Trial group |
| Normal Saline (NS)The control group used normal saline as the placebo for wet compress, and the hyperthermia treatment was the same as that of the trial group. | Drug | Control group |
Primary outcome
Complete clearance rate of warts within 6 months
Time frame: 6 months after the first time of treatment.
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
Recurrence rate of warts
Time frame: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.
Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
Complete clearance rate of warts within 3 months
Time frame: 3 months after the first time of treatment.
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments.
HPV genotyping
Time frame: Pre-treatment and 3,6 months after the first time of treatment
Collect the tissue sample from the wart for HPV gene testing.
Pathogenic Gene Screening Analysis
Time frame: Pre-treatment
Collecting patient blood samples for pathogenic gene screening
Immune-related cytokines
Time frame: Pre-treatment and 3,6 months after the first time of treatment
Collecting the patient's blood samples to test immune-related cytokines
5 secondary outcomes
Changes in the size and number of warts at different points in time
Time frame: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
Curative effect of different types of warts
Time frame: followed up at 6 months.
Occurrence of adverse events
Time frame: During treatment and follow-up
Treatment-related pain intensity
Time frame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180)
Patient satisfaction score
Time frame: At 6-month follow-up
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 4 May 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An infrared hyperthermia device, Hydrogen Peroxide 3 % Topical Solution and Normal Saline (NS) in people with Refactory Warts, run by First Hospital of China Medical University at 2 sites 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 2 inclusion and 4 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Xinghua Gao (024-83282524, gaobarry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance rate of warts within 6 months (time frame: 6 months after the first time of treatment.). The study lists 6 primary outcomes in all. 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 4 May 2026.