Treatment of latent or subclinical Genital HPV Infection with 5-aminolevulinic acid-based photodynamic therapy.
Zhili Hu, Junpeng Li, Hui Liu...
https://pubmed.ncbi.nlm.nih.gov/30048762/Actively Recruiting
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2025-05-13
40
Participants Needed
1
Research Sites
46 weeks
Total Duration
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
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
Y
YAN HU, PHD
K
kowthar mohamed shaie, master
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First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on treatment schedule; PDT involves three sessions, CO2 laser is a single session.
Participants receive either 5-ALA photodynamic therapy repeated three times or a single session of CO2 laser treatment to address persistent low-grade cervical lesions associated with high-risk HPV infection.
3 visits for PDT or 1 visit for CO2 laser treatment
Duration - 6 months
Participants are followed for 6 months after the last treatment session to assess lesion regression and monitor for adverse events.
Visits scheduled during the 6-month follow-up period
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor