Comparing two treatments for persistent low-grade cervical lesions caused by high-risk HPV

The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study

This study is testing whether a new light therapy or a laser treatment is better at helping women with long-lasting low-grade cervical lesions caused by high-risk HPV.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Wenzhou Medical University (Academic / other)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06052033 on ClinicalTrials.gov

What this trial studies

This non-randomized controlled trial compares the effectiveness of 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser treatment for women with persistent low-grade cervical lesions associated with high-risk HPV infection lasting over one year. The study aims to determine which treatment option is more effective in regressing or eliminating these cervical lesions. Participants will receive either 5-ALA photodynamic therapy or CO2 laser treatment, and the outcomes will be analyzed to provide insights into managing these conditions. The trial is designed to enhance understanding of treatment efficacy for women affected by high-risk HPV.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-65 with persistent low-grade cervical lesions and confirmed high-risk HPV infection for over one year.

Not a fit: Patients with a history of total hysterectomy or those with concurrent reproductive tract tumors will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for women with persistent low-grade cervical lesions due to high-risk HPV.

How similar studies have performed: While there have been studies on photodynamic therapy and laser treatments, this specific comparison is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-65 years old with a history of sexual activity.
2. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
4. No fundamental diseases of important organs.
5. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
6. There has been no history of using other drugs related to HPV infection in the past 3 months.

Exclusion Criteria:

1. HR-HPV persistent infection.
2. A total hysterectomy has been performed.
3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
6. Pregnant and lactating women.
7. Acute reproductive tract inflammation.
8. Diabetes patients with uncontrolled blood sugar.
9. Patients who do not receive full treatment and follow-up.
10. Those who fail to sign the informed consent form.

Where this trial is running

Wenzhou, Zhejiang

• first affiliated hospital of Wenzhou medical university — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yan Hu, Phd

Conditions HPV-Related Cervical Carcinoma; Low-Grade Squamous Intraepithelial Lesions; HPV Infection; Photodynamic Therapy; high-risk hpv infection; hpv persistent; Lsil; cervical lesions