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Efficacy and Safety Observation of Human Papillomavirus (HPV) Gel Dressing in the Treatment of High - risk HPV Infection

Efficacy and Safety Observation of Human Papillomavirus (HPV) Gel Dressing in the Treatment of High - risk HPV Infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103015
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk human papillomavirus infection

Interventions

Experimental Group:Participants in the experimental group will receive Anti-HPV gel dressing treatment, starting on the first day after the end of menstruation. The gel will be administered intravagin
Control group:Participants in the control group will not receive any intervention treatment related to HPV infection.

Sponsors

Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 Females aged =18 years with a history of sexual activity; 2 High-risk HPV infection confirmed by cervical HPV testing; 3 Normal cognitive and communication abilities, willingness to use effective contraception during the study, and abstinence from sexual intercourse during the treatment period; 4 Capable of complying with all study procedures and providing signed informed consent.

Exclusion criteria

Exclusion criteria: 1 Patients with HPV16 or HPV18 positivity and high-grade squamous intraepithelial lesion or worse (HSIL+); 2 Patients with other high-risk HPV subtypes (excluding HPV16/18) requiring further colposcopy; 3 Patients with cervical cancer; 4 Pregnant or lactating women; 5 Individuals with a history of allergies or known hypersensitivity to any component of the investigational gel dressing (e.g., carbomer); 6 Malignancy or other diseases that may compromise immune function.

Design outcomes

Primary

MeasureTime frame
Negative conversion rate;Total effective rate;

Secondary

MeasureTime frame
Vaginal microecosystem;

Countries

China

Contacts

Public ContactLyu Tao

Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

aimaoshu@126.com+86 136 0116 1831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026