Persistent HR-HPV Infection of the CervixPhase 4NCT07493824
Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
A Phase 4 study testing Patling ® Antibacterial Liquid in people with Persistent HR-HPV Infection of the Cervix, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection Read more about this study
- Who is it for?
- Ages 26 to 65 years, women only
- Conditions the study is for
- Persistent HR-HPV Infection of the Cervix
- What is being tested?
- Patling ® Antibacterial Liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2025to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Zhentong Wei Medic, 15804300686, zhentongwei2009@163.com
About this study
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
Read the 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.
- Being tested
- Patling ® Antibacterial Liquid
- Keywords
- Patling ® Antibacterial Liquid, Treatment for persistent HPV infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patling ® Antibacterial LiquidDrug
Apply Patling ® antibacterial solution locally to the cervix
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, prospective study of the efficacy and safety of Paiteling®Antibacterial Liquid in the tr | Experimental | Not described Receives: Drug: Patling ® Antibacterial Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
Cervical HR-HPV persistent infection HR-HPV seroconversion rate:
5 The rate of turning negative: refers to the reexamination of patients' HR-HPV at a specified time after the end of treatment. Turning negative is defined as the reversal of HR-HPV from persistently positive at enrollment to negative, including all HR-HPV being negative and the reversal of persistently positive HR-HPV to negative while other subtypes are positive. The HR-HPV of the subjects was reviewed 12 months after treatment, and the seroconversion rate of the subtypes of HR-HPV infection that persisted at the time of enrollment was observed and recorded, defined as the seroconversion at that time point.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start24 Jul 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent HR-HPV Infection of the CervixStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songling Zhang, The First Hospital of Jilin University
- Investigators
- Songling Zhang, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493824
- Sponsor's protocol ID
- 25K186-001
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Prospective Study of the Efficacy and Safety of Paiteling®Antibacterial Liquid in the Treatment of Persistent Cervical HR-HPV Infection
- ClinicalTrials.gov ID
- NCT07493824
- Acronym / sponsor ID
- 25K186-001
- Keywords
- Patling ® Antibacterial Liquid, Treatment for persistent HPV infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, prospective study of the efficacy and safety of Paiteling®Antibacterial Liquid in the tr | Experimental | Drug: Patling ® Antibacterial Liquid |
Who may qualify
- Ages
- 26 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patling ® Antibacterial LiquidApply Patling ® antibacterial solution locally to the cervix | Drug | Single-arm, prospective study of the efficacy and safety of Paiteling®Antibacterial Liquid in the tr |
Primary outcome
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection
Time frame: 24 months
Cervical HR-HPV persistent infection HR-HPV seroconversion rate: 5 The rate of turning negative: refers to the reexamination of patients' HR-HPV at a specified time after the end of treatment. Turning negative is defined as the reversal of HR-HPV from persistently positive at enrollment to negative, including all HR-HPV being negative and the reversal of persistently positive HR-HPV to negative while other subtypes are positive. The HR-HPV of the subjects was reviewed 12 months after treatment, and the seroconversion rate of the subtypes of HR-HPV infection that persisted at the time of enrollment was observed and recorded, defined as the seroconversion at that time point.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Songling Zhang principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patling ® Antibacterial Liquid in people with Persistent HR-HPV Infection of the Cervix, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaosen Li Li (+8618343116682, xiaosensen@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of Patellin ® antibacterial solution in treating persistent cervical HR-HPV infection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.