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

Recruiting now · Not applicable

Conditions studied: HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions, HPV Infection, Photodynamic Therapy

In brief

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

Key facts

Study ID

NCT06052033

Run by

First Affiliated Hospital of Wenzhou Medical University

People needed

40

Starts

2023-09-11

Expected to finish

2025-06-30

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-65 years old with a history of sexual activity.
• 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).
• Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
• No fundamental diseases of important organs.
• Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
• There has been no history of using other drugs related to HPV infection in the past 3 months.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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