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NCT Number: NCT06052033

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

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

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Key information

Conditions

HPV-Related Cervical Carcinoma Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Infection Infections Low-Grade Squamous Intraepithelial Lesions Morphological and Microscopic Findings Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Photodynamic Therapy Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Intraepithelial Lesions Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CO2

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

YAN HU, PHD

CONTACT

[email protected]

008613806696807

kowthar mohamed shaie, master

CONTACT

[email protected]

008615542452638

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 25, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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