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

Zhejiang University

Status and phase: Not yet enrolling; Phase 4

Conditions: Plantar Wart

Treatments: Drug: Bleomycin Injection; Drug: Pingyangmycin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07197541

2024-0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Bleomycin group

Experimental group

Treatment:

Drug: Bleomycin Injection

Pingyangmycin group

Experimental group

Treatment:

Drug: Pingyangmycin Injection