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Active, not recruitingNCT07197541Updated Jul 2, 2026

A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts

A Phase 4 interventional study of Hyperthermia Therapy and Pingyangmycin Injection in Plantar Wart, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Plantar Wart
03

In context

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged over 18 years old;
  2. Clinical diagnosis of plantar warts;
  3. The diameter of a single wart is ≥1cm, and the number is ≥2;
  4. There is a history of other treatments for plantar warts within 4 weeks, including drugs and physical therapy;
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. There are other local infections in the treatment area and injection is not suitable;
  2. Patients allergic to lidocaine, bleomycin, and pingyangmycin;
  3. Patients with other serious skin diseases, tumors or other systemic diseases;
  4. Patients with infections such as tuberculosis, HIV, hepatitis B, hepatitis C;
  5. Patients with a history of other treatments for plantar warts in the previous 4 weeks, including drugs and physical therapy;
  6. Patients who have participated in other clinical trials in the past 3 months;
  7. Pregnant women, lactating women, or patients who plan to become pregnant during the trial;
  8. Those who have any history of major surgery in the previous 8 weeks or who may have surgery planned during treatment;
  9. Patients with a history of mental illness.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Bleomycin group

    Drug: Bleomycin injection

  • Experimental
    Pingyangmycin group

    Drug: Pingyangmycin Injection

  • Experimental
    Hyperthermia therapy group

    Device: Hyperthermia Therapy

  • Experimental
    Bleomycin Combined with Local Hyperthermia

    Device: Hyperthermia Therapy · Drug: Bleomycin injection

Interventions

  • DeviceHyperthermia Therapy

    Device-mediated constant-temperature hyperthermia at approximately 44°C.

  • DrugPingyangmycin Injection

    Pingyangmycin injection treatment group: local injection treatment, once every 4 weeks.

  • DrugBleomycin injection

    Bleomycin injection treatment group: local injection treatment, once every 4 weeks.

06

What researchers measure

Primary outcomes

  1. Skin lesions completely cleared

    The patient's plantar wart lesions were completely cleared

    Time frame: 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.

    Time frame: Week 52

07

Study locations

1 site
  • The second Affiliated hospital of Zhejiang university school of medicine
    Hangzhou, Zhejiang 310009, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07197541
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Oct 1, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Jul 2, 2026

Study contacts

Jiong Zhou, PhD
principal investigator · Second Affiliated Hospital, Zhejiang University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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