Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Launched by FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments, 5-ALA photodynamic therapy and CO2 laser therapy, for women who have persistent low-grade cervical lesions caused by high-risk HPV (human papillomavirus) infection. The goal is to see which treatment is more effective in managing these conditions. The trial is currently recruiting female participants aged 18 to 65 who have been confirmed to have a high-risk HPV infection and have been diagnosed with low-grade cervical lesions through specific medical tests.

Eligible participants will need to be in good overall health and not have any serious underlying medical conditions. They should not have had any treatments related to HPV in the last three months and must agree to follow the study's treatment plan and provide informed consent. Those who join the trial can expect to receive one of the two treatments and will be monitored closely to assess how well it works. This study is important because it aims to find effective ways to treat cervical lesions linked to HPV, which can help prevent more serious health issues in the future.

Gender

FEMALE

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.