Actively Recruiting
Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus CO2 Laser in Treating Persistent Low-Grade Cervical Lesions with High-Risk HPV Infection A Non-randomized Controlled Trial
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2025-05-13
40
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different treatments for women who have had persistent low-grade cervical lesions caused by high-risk HPV infection for more than one year. The study compares 5-aminolevulinic acid 5-ALA photodynamic therapy with CO2 laser treatment to determine which approach may better reduce or eliminate these cervical lesions. This non-randomized controlled trial focuses on women aged 18 to 65 years with confirmed high-risk HPV-related lesions. Participants receive either 5-ALA photodynamic therapy, which involves applying a special cervical gel followed by 25 minutes of laser light exposure repeated three times, or CO2 laser therapy, which removes the cervical lesions in a single session by ablating tissue to a specific depth and width. Both treatments are designed to target persistent low-grade cervical lesions associated with high-risk HPV infection. During the study, women will be monitored for changes in their cervical lesions, with the main outcome measured six months after the last photodynamic therapy session or the CO2 laser treatment. Researchers will also check for any adverse effects six months following CO2 laser therapy. Participants will undergo examinations and follow-up visits as part of the treatment and assessment process, which continues until the study ends in June 2025.
CONDITIONS
Brief Title
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 65 years with a history of sexual activity
- Confirmed high-risk HPV positive for more than 1 year by HPV typing, mRNA, DNA tests, and cervical diagnostic procedures
- Diagnosed with low-grade squamous intraepithelial lesions (LSIL) by cervical biopsy after more than 1 year
- No serious diseases affecting important organs
- Willing to receive treatment and follow-up and sign informed consent
- No use of HPV-related drugs in the past 3 months
You will not qualify if you...
- Persistent high-risk HPV infection
- Previous total hysterectomy
- Presence of endometrial cancer, ovarian cancer, or other reproductive tract tumors
- Abnormal heart, liver, or kidney function, immune dysfunction, or immune system diseases like systemic lupus erythematosus
- Use of immunosuppressants, antiviral agents, or glucocorticoids
- Pregnant or breastfeeding women
- Acute reproductive tract inflammation
- Uncontrolled diabetes
- Failure to complete treatment and follow-up
- Refusal to sign informed consent form
Research Team
Y
YAN HU, PHD
K
kowthar mohamed shaie, master
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