Paiteling® antibacterial liquid for persistent cervical high‑risk HPV infection
Official title: Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
Run by The First Hospital of Jilin University · NCT07493824 · Data updated 2026-11-12
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 |
| Ages | 26 Years to 65 Years |
| Sex | Women only |
| Enrollment | 115 (estimated) |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Status | Recruiting |
| Started | July 24, 2025 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07493824 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Retroperitoneal Tumor Registry
This observational registry collects real-world data from people with retroperitoneal tumors to help understand features, treatments, and long-term outcomes.
-
Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
-
Vision-language AI helps emergency CT readers spot thoraco-abdominal problems
This trial tests whether a self-developed AI model can help radiologists find acute thoraco-abdominal emergencies on CT scans more accurately than standard reading in adult emergency patients.
-
Tegileridine for pain after bariatric surgery
This phase 3 trial tests tegileridine vs standard opioid medicine to see if it provides good pain relief after bariatric surgery while considering sleep apnea status.
-
Modular robotic surgery to remove GEJ cancers at Siewert II/III
This trial tests a modular robotic system to perform minimally invasive removal of Siewert type II/III gastroesophageal junction cancers in adults.
-
Removing enlarged cardiophrenic lymph nodes during surgery for advanced ovarian cancer
This will try removing enlarged cardiophrenic lymph nodes during surgery in women with advanced ovarian, fallopian tube, or primary peritoneal cancer to see if it delays cancer coming back and is safe.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.