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

Jilin University

Status and phase

Enrolling

Phase 4

Conditions

Persistent HR-HPV Infection of the Cervix

Treatments

Drug: Patling ® Antibacterial Liquid

Study type

Interventional

Funder types

Other

Identifiers

NCT07493824

25K186-001

Details and patient eligibility

About

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

Full 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.

Enrollment

115 estimated patients

Sex

Female

Ages

26 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1 、 Age 25 to 65 years (inclusive), persistent cervical HR-HPV infection (HR-HPV persistent infection refers to infection with the same high-risk HPV subtypes for ≥2 years (this can be from different testing companies; for multiple infections, only one subtyping of HPV persistence is required)); if the cervical biopsy shows chronic cervicitis or low-grade cervical intraepithelial neoplasia; 2. Sexual history; 3. No relevant anti-HPV virus treatment (vaginal or systemic) in the 3 months prior to visit; 4. No pregnancy plan within 6 months of visit 5、 Voluntary signing of informed consent.

Exclusion criteria

1、 Cervical biopsy results of TCT or HSIL; 2 、 Cervical HR-HPV infection subtypes changed or reversed to negative; 3. Pregnant or lactating women; 4. Acute inflammation of the genital tract; 5Recent immunodeficiency (chemoradiotherapy, AIDS, SLE); 6. Patients with severe diseases such as diabetes, cardiovascular disease, brain, liver, kidney and hematopoietic system, and mental illness; 7. Those with a history of drug allergy and allergic constitution; 8 Patients who have participated in other clinical trials in the last three months; 9. Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in work environment and unstable living environment that are likely to cause loss of follow-up, according to the investigator's judgment.