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

Not Applicable

Recruiting

• Conditions: Photodynamic Therapy; HPV-Related Cervical Carcinoma; HPV Infection; Low-Grade Squamous Intraepithelial Lesions
• Interventions: Procedure: CO2

• Registration Number: NCT06052033
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

Detailed Description

This non-randomized controlled trial aims to compare the effectiveness of two treatments, 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser, for women with persistent low-grade cervical lesions associated with high-risk HPV infection lasting more than one year. The study's primary objective is to assess which treatment option yields better results. Participants in both groups will undergo specific therapeutic procedures, including 5-ALA photodynamic therapy or CO2 laser treatment. The study will analyze and compare the effects of these therapies on the regression or elimination of cervical lesions, offering valuable insights into the management of persistent low-grade cervical lesions among high-risk HPV-infected women.

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Primary Completion: 2024-08-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALA-PDT Group	CO2	PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.
CO2 Laser Group	CO2	CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session.

Primary Outcome Measures

Name	Time	Method
Regression of Cervical Lesions.	Assessed at 6 months after the last PDT session.	Measure the rate of regression in cervical lesions after three PDT sessions.

Secondary Outcome Measures

Name	Time	Method
Adverse Events.	Evaluated at 6 months after the CO2 laser treatment.	Monitor and document any adverse events or complications related to CO2 laser treatment.

Trial Locations

Locations (1)

first affiliated hospital of Wenzhou medical university; 🇨🇳 Wenzhou, Zhejiang, China