NCT07493824

Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: Female
• Age: 26 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection

Detailed description

This study is a single-arm, single-center clinical study ® The study was designed to determine the safety of Patelin antibacterial solution in patients with persistent cervical HR-HPV infection availability. The study primarily aims to evaluate the seroconversion rate of cervical HR-HPV in persistent HR-HPV carriers; simultaneously, it compares the positivity rates and copy levels of HPV E6/E7mRNA, changes in gynecological microecology, vaginal immune status, assessment of vaginal irritability, and initial evaluation of adult vaginitis before and after enrollment Safety and tolerability of Cephatin antibacterial solution in the treatment of persistent cervical HR-HPV infection. Informed consent 7 ® was obtained Patients with persistent cervical HR-HPV infection were given standard treatment of Patelin® antibacterial solution for 6 courses. This study is a single-arm, single-center clinical study, which is divided into screening period, drug administration period and follow-up period The screening period was 7d. After signing the informed consent form, the subjects entered the screening period, and those who passed the screening period were admitted to the study. The dosing period is 2 months. After the subjects are enrolled, the vaginal administration will be performed by professional personnel from Patlin Company. Patients should start applying Patlin® antibacterial solution to the cervix 3-4 days after their menstrual period ends: Use 1-2ml of Patlin diluted solution at a ratio of 1:50 (distilled water) to clean the external genitalia and clear vaginal secretions. Then, apply 3ml of the original Patlin solution onto a sterile cotton ball with a tail, and use it for local application to the cervix once daily for 3 hours each time before removing it. Continue for 3 days, then stop for 7 days, making a total course of 10 days, with a total of 6 courses (for those in their menstrual cycle 8 For menstrual patients, the medication can be started after menstruation has ended); avoid using during menstruation, and abstain from sexual activity during the medication period. During the medication period, perform colposcopy, vaginal irritation assessment, initial evaluation of adult vaginitis, and collection of vaginal secretion samples to assess safety, tolerability, and efficacy. The follow-up period is 22 months, with rechecks conducted at 6, 12,18, and 24 months post-treatment for follow-up visits. Colposcopy, vaginal irritation assessment, initial evaluation of adult vaginitis, and collection of vaginal secretion samples are performed. If necessary, patients are referred for colposcopy and cervical biopsy for pathological examination to assess safety, tolerability, and efficacy. The study collects and records the participants' HPV infection status, vaginal microecological state, local immune factors, and changes in cervical lesions.

Conditions

• Persistent HR-HPV Infection of the Cervix

Interventions

Type	Name	Description
DRUG	Patling ® Antibacterial Liquid	Apply Patling ® antibacterial solution locally to the cervix

Timeline

• Start date: 2025-07-24
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China