A Randomized Controlled Trial to Evaluate the Effectiveness of Bleomycin and Cryotherapy in Treating Plantar Warts.

March 20, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 310000
        • Recruiting
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bleomycin Group
Other: Bleomycin injection
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
Other: cryotherapy
Other: Cryotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of warts complete clearance
Time Frame: 2 weeks after treatment endpoint
2 weeks after treatment endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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