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

Sponsor

First Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06052033

Collaborator

(none)

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HPV-Related Cervical Carcinoma Low-Grade Squamous Intraepithelial Lesions HPV Infection Photodynamic Therapy	Procedure: CO2	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Aug 10, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALA-PDT Group PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.	Procedure: CO2 CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.
Other: CO2 Laser Group CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session.	Procedure: CO2 CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.

Arm

Intervention/Treatment

Experimental: ALA-PDT Group

PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.

Procedure: CO2

CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.

Other: CO2 Laser Group

CO2 laser therapy ablates cervical lesions with a depth of 7-10mm and a width of 3-5mm in a single session.

Procedure: CO2

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.