WartsNCT07534865
Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts
A study testing 3% hydrogen peroxide solution, 0.9 % saline and Hyperthermia at 44℃ in people with Warts, run by First Hospital of China Medical University at 1 site in China.
Trial summary
Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Warts
- What is being tested?
- 3% hydrogen peroxide solution, 0.9 % saline and Hyperthermia at 44℃
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Dec 2028
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 6-65 years, male or female;
- Clinically diagnosed with common warts, palmar/plantar/digital warts (≥1 lesion), with a Physician's Wart Assessment score ≥2 (0: no visible wart, no further treatment required; 1: visible wart, diameter <3 mm; 2: single wart diameter ≥3 mm and <6 mm; 3: single wart diameter ≥6 mm);
- The subject or legal guardian is able to understand and sign the informed consent form and agrees to participate in the study.
Who cannot join
- Subjects presenting with atypical warts clinically;
- Subjects with immune dysfunction or autoimmune diseases;
- Pregnant or breastfeeding women;
- Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months;
- Subjects who have undergone the following systemic treatments within the specified time frames: immunomodulators/immunosuppressants (e.g., etanercept), within 4 months; corticosteroids (inhaled and intranasal use permitted), within 1 month;
- Subjects who have received the following treatments on or around the warts within the specified time frames: laser or other photochemical therapies (intense pulsed light, photodynamic therapy), within 3 months; immunotherapy (candida antigen), within 4 months; cryotherapy with liquid nitrogen, within 2 months; hydrogen peroxide, within 3 months; antimetabolite therapy (5-fluorouracil), within 2 months; retinoids, within 3 months;
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- Subjects with a history of the following diseases prior to enrollment: skin malignancy within the past 6 months, premalignant skin conditions (actinic keratosis) within the past 6 months, or currently in the acute progressive phase of skin or systemic diseases (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.) or presenting with conditions (such as sunburn, open wounds) that may increase the risk of participation or interfere with evaluation;
- Subjects with diseases affecting skin healing, such as diabetes mellitus, vitamin A deficiency, etc.;
- Subjects with cold-sensitive conditions such as cryoglobulinemia or cold urticaria that may lead to abnormal observation results;
- Subjects with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, or other vital organs.
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
Infrared Hyperthermia Device
Shenyang
Hao Guo, +86 13840365892, guohao27@126.com
About this study
Official title: A Randomized, Parallel-Group, Controlled, Assessor-Blinded Clinical Trial of Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts
Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc. Significant progress has been made in the application of hyperthermia for viral skin diseases. Clinically, the addition of hydrogen peroxide solution can enhance the efficacy of hyperthermia in treating HPV infection. As a common transdermal drug delivery method, microneedles can increase drug penetration and thereby further improve treatment outcomes. Based on these findings, this study aims to explore an adjunctive approach to hyperthermia for treating viral warts to further enhance therapeutic efficacy.
This study employs a randomized, parallel-group, assessor-blinded design. Participants will be randomly assigned to three groups: hyperthermia alone, hyperthermia combined with microneedle patch (loaded with 0.9% saline), and hyperthermia combined with hydrogen peroxide microneedle patch (experimental group). An adaptive design will be adopted. The sample size is estimated at 70 participants per group, accounting for a potential 20% dropout rate. Interim analyses will be conducted during follow-up, and enrollment will be stopped when a positive result is reached for the primary efficacy endpoint (cure rate), at which point the sample size will be adjusted accordingly.
- Conditions
- Warts
- Being tested
- 3% hydrogen peroxide solution, 0.9 % saline, Hyperthermia at 44℃, Microneedle patch
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% hydrogen peroxide solutionDrug
Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 3% hydrogen peroxide . Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
0.9 % salineDrug
Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 0.9% saline. Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
Hyperthermia at 44℃Device
The infrared hyperthermia device was used as follows: based on the thermal tolerance of different body surface areas, the surface temperature was set to 44 °C ± 1 °C. The lesion was disinfected with alcohol. After the skin had dried, the patient's most painful or largest wart was selected as the target lesion and treated with 44 °C hyperthermia. The treatment was administered for three consecutive days (sessions), each lasting 30 minutes. After an interval of 7-10 days, the same target lesion received two consecutive days (sessions) of treatment, followed by one session every 7-10 days thereafter. For patients with multiple lesions, only one target lesion was treated using the above protocol, while the remaining lesions received no intervention.
Microneedle patchDevice
Purpose: To facilitate drug loading. Instructions:Add an appropriate amount of 3% hydrogen peroxide solution or 0.9% sodium chloride solution into the corresponding chamber. Apply the microneedle patch to the wart and secure it with tape. Press the raised part of the aluminum film sequentially with fingers until the chamber fully collapses and makes contact with the skin. After one hour of contact, dispose of the patch in a medical waste container.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia at 44°C | Experimental | Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia. Receives: Drug: 0.9 % saline; Device: Hyperthermia at 44℃ |
| Hyperthermia combined with microneedle patch (loaded with 0.9% saline) | Experimental | One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks. Receives: Drug: 0.9 % saline; Device: Hyperthermia at 44℃; Device: Microneedle patch |
| Hyperthermia combined with hydrogen peroxide microneedle patch | Experimental | One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks. Receives: Drug: 3% hydrogen peroxide solution; Device: Hyperthermia at 44℃; Device: Microneedle patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance rate of warts
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.
Time to complete clearance
Median duration from first treatment to complete resolution (days)
Measured: 6 months after the first time of treatment.
Recurrence rate of warts
Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and 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 months after treatment.
Secondary outcomes (4)
Changes in the size and number of warts at different points in time
Measured: At months 1, 3, and 6
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)
Time to first wart clearance
Measured: At months 1, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 210 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
- NCT07534865
- Sponsor's protocol ID
- 【2025】770
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Controlled, Assessor-Blinded Clinical Trial of Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts
- ClinicalTrials.gov ID
- NCT07534865
- Acronym / sponsor ID
- 【2025】770
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Apr 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.
Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc. Significant progress has been made in the application of hyperthermia for viral skin diseases. Clinically, the addition of hydrogen peroxide solution can enhance the efficacy of hyperthermia in treating HPV infection. As a common transdermal drug delivery method, microneedles can increase drug penetration and thereby further improve treatment outcomes. Based on these findings, this study aims to explore an adjunctive approach to hyperthermia for treating viral warts to further enhance therapeutic efficacy.
This study employs a randomized, parallel-group, assessor-blinded design. Participants will be randomly assigned to three groups: hyperthermia alone, hyperthermia combined with microneedle patch (loaded with 0.9% saline), and hyperthermia combined with hydrogen peroxide microneedle patch (experimental group). An adaptive design will be adopted. The sample size is estimated at 70 participants per group, accounting for a potential 20% dropout rate. Interim analyses will be conducted during follow-up, and enrollment will be stopped when a positive result is reached for the primary efficacy endpoint (cure rate), at which point the sample size will be adjusted accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia at 44°C | Experimental | Drug: 0.9 % saline, Device: Hyperthermia at 44℃Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia. |
| Hyperthermia combined with microneedle patch (loaded with 0.9% saline) | Experimental | Drug: 0.9 % saline, Device: Hyperthermia at 44℃, Device: Microneedle patchOne wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks. |
| Hyperthermia combined with hydrogen peroxide microneedle patch | Experimental | Drug: 3% hydrogen peroxide solution, Device: Hyperthermia at 44℃, Device: Microneedle patchOne wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 6-65 years, male or female;
- Clinically diagnosed with common warts, palmar/plantar/digital warts (≥1 lesion), with a Physician's Wart Assessment score ≥2 (0: no visible wart, no further treatment required; 1: visible wart, diameter <3 mm; 2: single wart diameter ≥3 mm and <6 mm; 3: single wart diameter ≥6 mm);
- The subject or legal guardian is able to understand and sign the informed consent form and agrees to participate in the study.
Key exclusion criteria (10 listed)
- Subjects presenting with atypical warts clinically;
- Subjects with immune dysfunction or autoimmune diseases;
- Pregnant or breastfeeding women;
- Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months;
- Subjects who have undergone the following systemic treatments within the specified time frames: immunomodulators/immunosuppressants (e.g., etanercept), within 4 months; corticosteroids (inhaled and intranasal use permitted), within 1 month;
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 |
|---|---|---|
| 3% hydrogen peroxide solutionDressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 3% hydrogen peroxide . Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. | Drug | Hyperthermia combined with hydrogen peroxide microneedle patch |
| 0.9 % salineDressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 0.9% saline. Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts. | Drug | Hyperthermia at 44°C, Hyperthermia combined with microneedle patch (loaded with 0.9% saline) |
| Hyperthermia at 44℃The infrared hyperthermia device was used as follows: based on the thermal tolerance of different body surface areas, the surface temperature was set to 44 °C ± 1 °C. The lesion was disinfected with alcohol. After the skin had dried, the patient's most painful or largest wart was selected as the target lesion and treated with 44 °C hyperthermia. The treatment was administered for three consecutive days (sessions), each lasting 30 minutes. After an interval of 7-10 days, the same target lesion received two consecutive days (sessions) of treatment, followed by one session every 7-10 days thereafter. For patients with multiple lesions, only one target lesion was treated using the above protocol, while the remaining lesions received no intervention. | Device | Hyperthermia at 44°C, Hyperthermia combined with hydrogen peroxide microneedle patch, Hyperthermia combined with microneedle patch (loaded with 0.9% saline) |
| Microneedle patchPurpose: To facilitate drug loading. Instructions:Add an appropriate amount of 3% hydrogen peroxide solution or 0.9% sodium chloride solution into the corresponding chamber. Apply the microneedle patch to the wart and secure it with tape. Press the raised part of the aluminum film sequentially with fingers until the chamber fully collapses and makes contact with the skin. After one hour of contact, dispose of the patch in a medical waste container. | Device | Hyperthermia combined with hydrogen peroxide microneedle patch, Hyperthermia combined with microneedle patch (loaded with 0.9% saline) |
Primary outcome
Complete clearance rate of warts
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.
Time to complete clearance
Time frame: 6 months after the first time of treatment.
Median duration from first treatment to complete resolution (days)
Recurrence rate of warts
Time frame: Recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.
Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
4 secondary outcomes
Changes in the size and number of warts at different points in time
Time frame: At months 1, 3, and 6
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)
Time to first wart clearance
Time frame: At months 1, 3, and 6
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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 3% hydrogen peroxide solution, 0.9 % saline and Hyperthermia at 44℃ in people with Warts, 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 10 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 16 Apr 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 Hao Guo (+86 13840365892, guohao27@126.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 (time frame: 6 months after the first time of treatment.). The study lists 3 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 16 Apr 2026.