Plantar Wart
Conditions
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.
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.
Bleomycin injection treatment group: local injection treatment, once every 4 weeks.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin lesions completely cleared | Week 24 | The patient's plantar wart lesions were completely cleared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow up to 36 weeks with no recurrence | Week 52 | There was no recurrence of plantar warts in the patient at 36 weeks of follow-up. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJiong Zhou, PhD
Second Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed