Paiteling® antibacterial liquid for persistent cervical high‑risk HPV infection
Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
This trial will test whether Paiteling® antibacterial liquid applied to the cervix can clear persistent high‑risk HPV infection in women aged 25–65.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 26 Years to 65 Years |
| Sex | Female |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07493824 on ClinicalTrials.gov |
What this trial studies
This is a single‑arm, single‑center, prospective Phase 4 study in which women with persistent cervical high‑risk HPV receive six courses of Paiteling® vaginal administration over a two‑month dosing period, with screening and follow‑up visits. Dosing is performed by trained personnel and begins a few days after the end of menstruation, using a diluted topical preparation applied to the cervix. Primary outcomes include HPV seroconversion/clearance rate; secondary measures include HPV E6/E7 mRNA positivity and copy number, changes in gynecologic microecology, vaginal immune markers, and tolerability including local irritation and vaginitis assessment. Participants are screened for eligibility (age 25–65, same HR‑HPV subtype persistent ≥2 years) and excluded for HSIL on biopsy, changing HPV subtypes, pregnancy, acute genital infection, severe comorbidity, or recent immunosuppression.
Who should consider this trial
Good fit: Women 25–65 years old with the same high‑risk cervical HPV subtype documented as persistent for at least two years, not pregnant or lactating, with no recent anti‑HPV treatment, and willing to attend the single center in Changchun.
Not a fit: Patients with biopsy‑proven HSIL, changing or newly negative HPV subtypes, active genital infection, pregnancy, significant immunodeficiency, or major uncontrolled comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could clear persistent high‑risk HPV infections and reduce the risk of progression to more serious cervical disease, potentially avoiding invasive interventions.
How similar studies have performed: Small observational and open‑label studies of topical herbal or proprietary preparations including Paiteling® have reported some positive clearance rates, but high‑quality randomized evidence is limited and results are not widely confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Changchun, Jilin
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Principal investigator: Songling Zhang — The First Hospital of Jilin University
- Study coordinator: Xiaosen Li Li
- Email: xiaosensen@jlu.edu.cn
- Phone: +8618343116682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.