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

NCT ID: NCT07197541

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bleomycin group

Group Type: EXPERIMENTAL

Bleomycin Injection

Intervention Type: DRUG

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

Pingyangmycin group

Group Type: EXPERIMENTAL

Pingyangmycin Injection

Intervention Type: DRUG

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

Interventions

Bleomycin Injection

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

Intervention Type: DRUG

Pingyangmycin Injection

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

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiong Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, Zhejiang University School of Medicine

Central Contacts

Jiong Zhou, PhD

Role: CONTACT

jojozju@zju.edu.cn

+8613588342979

Other Identifiers

2024-0001

Identifier Type: -

Identifier Source: org_study_id