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NCT Number: NCT06718192

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Lunfei Liu, Master

CONTACT

[email protected]

17816698735

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bleomycin injection

Other

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

Cryotherapy

Other

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

Primary outcomes

  1. the rate of warts complete clearance

    Time frame: 2 weeks after treatment endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Lunfei Liu, Master

CONTACT

[email protected]

17816698735

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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