Plantar WartPhase 4NCT07197541
A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts
A Phase 4 study testing Hyperthermia Therapy, Pingyangmycin Injection and Bleomycin injection in people with Plantar Wart, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
All patients were treated as self-control. Half of the warts received bleomycin injection and the other half received pingyangmycin injection for 24 weeks. During the treatment period, before each injection, photos of the skin lesions must be taken, the diameter of the skin lesions must be measured, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Hyperthermia Therapy, Pingyangmycin Injection and Bleomycin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Nov 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years old;
- Clinical diagnosis of plantar warts;
- The diameter of a single wart is ≥1cm, and the number is ≥2;
- There is a history of other treatments for plantar warts within 4 weeks, including drugs and physical therapy;
- Have a basic understanding of the purpose, effects and possible adverse reactions of the trial, and sign an informed consent form in accordance with the spirit of the Declaration of Helsinki.
Who cannot join
- There are other local infections in the treatment area and injection is not suitable;
- Patients allergic to lidocaine, bleomycin, and pingyangmycin;
- Patients with other serious skin diseases, tumors or other systemic diseases;
- Patients with infections such as tuberculosis, HIV, hepatitis B, hepatitis C;
- Patients with a history of other treatments for plantar warts in the previous 4 weeks, including drugs and physical therapy;
- Patients who have participated in other clinical trials in the past 3 months;
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- Pregnant women, lactating women, or patients who plan to become pregnant during the trial;
- Those who have any history of major surgery in the previous 8 weeks or who may have surgery planned during treatment;
- Patients with a history of mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, 310009
About this study
All patients were treated as self-control. Half of the warts received bleomycin injection and the other half received pingyangmycin injection for 24 weeks. During the treatment period, before each injection, photos of the skin lesions must be taken, the diameter of the skin lesions must be measured, the DLQI(Dermatology Life Quality Index) and NRS scores(NRS scores) must be filled in, and adverse events must be recorded. Before the first treatment, HPV(Human Papilloma virus) virus typing is performed on the warts.
- Conditions
- Plantar Wart
- Being tested
- Hyperthermia Therapy, Pingyangmycin Injection, Bleomycin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia TherapyDevice
Device-mediated constant-temperature hyperthermia at approximately 44°C.
Pingyangmycin InjectionDrug
Pingyangmycin injection treatment group: local injection treatment, once every 4 weeks.
Bleomycin injectionDrug
Bleomycin injection treatment group: local injection treatment, once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin group | Experimental | Not described Receives: Drug: Bleomycin injection |
| Pingyangmycin group | Experimental | Not described Receives: Drug: Pingyangmycin Injection |
| Hyperthermia therapy group | Experimental | Not described Receives: Device: Hyperthermia Therapy |
| Bleomycin Combined with Local Hyperthermia | Experimental | Not described Receives: Device: Hyperthermia Therapy; Drug: Bleomycin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin lesions completely cleared
The patient's plantar wart lesions were completely cleared
Measured: Week 24
Secondary outcomes (1)
Follow up to 36 weeks with no recurrence
There was no recurrence of plantar warts in the patient at 36 weeks of follow-up.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiong Zhou, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197541
- Sponsor's protocol ID
- 2024-0001
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT07197541
- Acronym / sponsor ID
- 2024-0001
- Conditions
- Plantar Wart
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
All patients were treated as self-control. Half of the warts received bleomycin injection and the other half received pingyangmycin injection for 24 weeks. During the treatment period, before each injection, photos of the skin lesions must be taken, the diameter of the skin lesions must be measured, the DLQI(Dermatology Life Quality Index) and NRS scores(NRS scores) must be filled in, and adverse events must be recorded. Before the first treatment, HPV(Human Papilloma virus) virus typing is performed on the warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bleomycin group | Experimental | Drug: Bleomycin injection |
| Pingyangmycin group | Experimental | Drug: Pingyangmycin Injection |
| Hyperthermia therapy group | Experimental | Device: Hyperthermia Therapy |
| Bleomycin Combined with Local Hyperthermia | Experimental | Device: Hyperthermia Therapy, Drug: Bleomycin injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18 years old;
- Clinical diagnosis of plantar warts;
- The diameter of a single wart is ≥1cm, and the number is ≥2;
- There is a history of other treatments for plantar warts within 4 weeks, including drugs and physical therapy;
- Have a basic understanding of the purpose, effects and possible adverse reactions of the trial, and sign an informed consent form in accordance with the spirit of the Declaration of Helsinki.
Key exclusion criteria (9 listed)
- There are other local infections in the treatment area and injection is not suitable;
- Patients allergic to lidocaine, bleomycin, and pingyangmycin;
- Patients with other serious skin diseases, tumors or other systemic diseases;
- Patients with infections such as tuberculosis, HIV, hepatitis B, hepatitis C;
- Patients with a history of other treatments for plantar warts in the previous 4 weeks, including drugs and physical therapy;
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 |
|---|---|---|
| Hyperthermia TherapyDevice-mediated constant-temperature hyperthermia at approximately 44°C. | Device | Bleomycin Combined with Local Hyperthermia, Hyperthermia therapy group |
| Pingyangmycin InjectionPingyangmycin injection treatment group: local injection treatment, once every 4 weeks. | Drug | Pingyangmycin group |
| Bleomycin injectionBleomycin injection treatment group: local injection treatment, once every 4 weeks. | Drug | Bleomycin Combined with Local Hyperthermia, Bleomycin group |
Primary outcome
Skin lesions completely cleared
Time frame: Week 24
The patient's plantar wart lesions were completely cleared
1 secondary outcome
Follow up to 36 weeks with no recurrence
Time frame: Week 52
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 2 Jul 2026.
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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. This study is not recruiting at the moment.
Jiong Zhou, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperthermia Therapy, Pingyangmycin Injection and Bleomycin injection in people with Plantar Wart, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin lesions completely cleared (time frame: Week 24). 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 2 Jul 2026.