Verruca PlantarisPhase 1/2NCT06718192
A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.
A Phase 1/2 study testing Bleomycin injection and Cryotherapy in people with Verruca Plantaris, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
To evaluate the efficacy of bleomycin and cryopreservation in the treatment of plantar verruca by dermoscopy and explore the influencing factors. Compare the safety, economic burden and impact on quality of life of the two treatments Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Verruca Plantaris
- What is being tested?
- Bleomycin injection and Cryotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 30 Jun 2025
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, gender is not limited; Consistent with the diagnosis of plantar warts; Volunteer for treatment and sign informed consent; Consent to photograph the lesion; The treatment target area can be selected (the target area must meet the following conditions: The distance between adjacent warts in the target area is >0.5cm; The diameter of a single wart in the target area is ≤1.5cm, and/or the diameter of a wart mass is ≤1.5cm; The number of total warts/wart masses in the target area is ≤10).
Who cannot join
- Patients who can't sign informed consent; Had previously received local treatment for common warts within 1 month; hiv-positive patient; Pregnant and lactating women; Has peripheral vascular disease; Allergic to bleomycin; People who are severely immunocompromised, or who are taking immunosuppressive drugs; Mental illness or cognitive incapacity; Other conditions deemed unsuitable for inclusion, such as inability to cooperate with follow-up, were considered by the researchers.
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
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, 310000
Lunfei Liu, Master, 17816698735, liulunfei_zeyy@163.com
About this study
To evaluate the efficacy of bleomycin and cryopreservation in the treatment of plantar verruca by dermoscopy and explore the influencing factors. Compare the safety, economic burden and impact on quality of life of the two treatments
Read the detailed description
Our research aims to evaluate and compare the effectiveness of bleomycin and cryotherapy in treating plantar warts. First, we enrolled patients according to eligibility criteria. Second, the patients were assigned to two groups randomly. One is Bleomycin Group and the other is Cryotherapy Group which means two -group-patients were received different therapies. Thirdly, we compared the efficiency of two groups by using dermoscopy. Finnally, we used statistical analysis to analyze the research data and draw the experimental conclusions.
- Conditions
- Verruca Plantaris
- Being tested
- Bleomycin injection, Cryotherapy
- Keywords
- verruca plantaris, Bleomycin, cryotherapy, efficiency, security
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin injectionOther
Wart injection (0.2 mL <5 mm; 0.5 mL 5-10 mm; 1ml for >10 mm) were injected at a depth of 1.5mm, diluted with normal saline at a concentration of 3u/ml=3mg/ml, and the maximum amount of each wart was 1ml until the wart turned white
CryotherapyOther
The wart was frozen by liquid nitrogen until a circle of frozen tissue appeared around the wart for about 10s, with an interval of 30s, for a total of 2 times
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin Group | Active comparator | Not described Receives: Other: Bleomycin injection |
| cryotherapy | Other | Not described Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of warts complete clearance
Measured: 2 weeks after treatment endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start25 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verruca PlantarisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718192
- Sponsor's protocol ID
- KY-2024-206
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2024
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.
- ClinicalTrials.gov ID
- NCT06718192
- Acronym / sponsor ID
- KY-2024-206
- Conditions
- Verruca Plantaris
- Keywords
- verruca plantaris, Bleomycin, cryotherapy, efficiency, security
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Dec 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.
To evaluate the efficacy of bleomycin and cryopreservation in the treatment of plantar verruca by dermoscopy and explore the influencing factors. Compare the safety, economic burden and impact on quality of life of the two treatments
Detailed description
Our research aims to evaluate and compare the effectiveness of bleomycin and cryotherapy in treating plantar warts. First, we enrolled patients according to eligibility criteria. Second, the patients were assigned to two groups randomly. One is Bleomycin Group and the other is Cryotherapy Group which means two -group-patients were received different therapies. Thirdly, we compared the efficiency of two groups by using dermoscopy. Finnally, we used statistical analysis to analyze the research data and draw the experimental conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bleomycin Group | Active comparator | Other: Bleomycin injection |
| cryotherapy | Other | Other: Cryotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years old, gender is not limited; Consistent with the diagnosis of plantar warts; Volunteer for treatment and sign informed consent; Consent to photograph the lesion; The treatment target area can be selected (the target area must meet the following conditions: The distance between adjacent warts in the target area is >0.5cm; The diameter of a single wart in the target area is ≤1.5cm, and/or the diameter of a wart mass is ≤1.5cm; The number of total warts/wart masses in the target area is ≤10).
Key exclusion criteria (1 listed)
- Patients who can't sign informed consent; Had previously received local treatment for common warts within 1 month; hiv-positive patient; Pregnant and lactating women; Has peripheral vascular disease; Allergic to bleomycin; People who are severely immunocompromised, or who are taking immunosuppressive drugs; Mental illness or cognitive incapacity; Other conditions deemed unsuitable for inclusion, such as inability to cooperate with follow-up, were considered by the researchers.
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 |
|---|---|---|
| Bleomycin injectionWart injection (0.2 mL <5 mm; 0.5 mL 5-10 mm; 1ml for >10 mm) were injected at a depth of 1.5mm, diluted with normal saline at a concentration of 3u/ml=3mg/ml, and the maximum amount of each wart was 1ml until the wart turned white | Other | Bleomycin Group |
| CryotherapyThe wart was frozen by liquid nitrogen until a circle of frozen tissue appeared around the wart for about 10s, with an interval of 30s, for a total of 2 times | Other | cryotherapy |
Primary outcome
the rate of warts complete clearance
Time frame: 2 weeks after treatment endpoint
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 24 Mar 2025.
- 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 Phase 1/2 study testing Bleomycin injection and Cryotherapy in people with Verruca Plantaris, run by The Fourth Affiliated Hospital of 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 1 inclusion and 1 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 24 Mar 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lunfei Liu, Master (17816698735, liulunfei_zeyy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of warts complete clearance (time frame: 2 weeks after treatment endpoint). 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 24 Mar 2025.