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

NCT07197541 | Active Not Recruiting Phase 4

• 1 other identifier: 2024-0001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (1)

• Skin lesions completely cleared

  The patient's plantar wart lesions were completely cleared

  Week 24

Secondary Outcomes (1)

• Follow up to 36 weeks with no recurrence

  Week 52

Study Arms (4)

Bleomycin group

EXPERIMENTAL

Drug: Bleomycin injection

Pingyangmycin group

EXPERIMENTAL

Drug: Pingyangmycin Injection

Hyperthermia therapy group

EXPERIMENTAL

Device: Hyperthermia Therapy

Bleomycin Combined with Local Hyperthermia

EXPERIMENTAL

Device: Hyperthermia Therapy; Drug: Bleomycin injection

Interventions

Bleomycin injection DRUG

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

Bleomycin Combined with Local Hyperthermia; Bleomycin group

Pingyangmycin Injection DRUG

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

Pingyangmycin group

Hyperthermia Therapy DEVICE

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

Bleomycin Combined with Local Hyperthermia; Hyperthermia therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second Affiliated hospital of Zhejiang university school of medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Diathermy; bleomycetin; Bleomycin

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jiong Zhou, PhD

  Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

CN (1)