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

September 23, 2023 updated by: YANHU, First Affiliated Hospital of Wenzhou Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325015
        • Recruiting
        • First affiliated hospital of Wenzhou medical university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of Cervical Lesions.
Time Frame: Assessed at 6 months after the last PDT session.
Measure the rate of regression in cervical lesions after three PDT sessions.
Assessed at 6 months after the last PDT session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events.
Time Frame: Evaluated at 6 months after the CO2 laser treatment.
Monitor and document any adverse events or complications related to CO2 laser treatment.
Evaluated at 6 months after the CO2 laser treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Estimated)

August 10, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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