Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
ID06718192

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

Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-03-24

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two treatments, bleomycin injection and cryotherapy, for plantar warts (Verruca Plantaris). This randomized controlled trial aims to compare how well these treatments work using dermoscopy, as well as assess their safety, economic impact, and effects on quality of life. The study includes adult participants aged 18 to 65 years with diagnosed plantar warts. Participants are randomly assigned to one of two groups: the Bleomycin Group or the Cryotherapy Group. The bleomycin treatment involves injecting a diluted solution directly into the wart based on its size, while the cryotherapy treatment uses liquid nitrogen to freeze the wart twice with a 30-second interval. The effectiveness of each treatment is evaluated two weeks after the treatment ends. During the study, patients will undergo assessments including dermoscopic examination of the warts and photographic documentation of the lesions. Researchers will monitor the complete clearance rate of warts as the primary outcome. Safety and other impacts such as quality of life and cost will also be tracked. The total study duration and specific visit schedules are based on treatment and follow-up timelines ending in mid-2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old, any gender
  • Diagnosed with plantar warts
  • Volunteer for treatment and able to sign informed consent
  • Agree to have lesion photographs taken
  • Target treatment area meets these: distance between warts >0.5 cm; single wart diameter ≤1.5 cm or wart mass diameter ≤1.5 cm; total number of warts or wart masses in target area ≤10
Not Eligible

You will not qualify if you...

  • Unable to sign informed consent
  • Received local treatment for common warts within the past month
  • HIV-positive
  • Pregnant or breastfeeding
  • Have peripheral vascular disease
  • Allergic to bleomycin
  • Severely immunocompromised or taking immunosuppressive drugs
  • Have mental illness or cognitive impairment
  • Other conditions making participation unsuitable, such as inability to cooperate with follow-up as judged by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session with follow-up at 2 weeks

Participants receive either bleomycin injections or cryotherapy to treat plantar warts.

1 treatment visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, China, 310000

Actively Recruiting

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Research Team

L

Lunfei Liu, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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