Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06052033

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

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

first affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, China, 325015

Actively Recruiting

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Research Team

Y

YAN HU, PHD

K

kowthar mohamed shaie, master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...

https://pubmed.ncbi.nlm.nih.gov/33538338

Distribution and role of high-risk human papillomavirus genotypes in women with cervical intraepithelial neoplasia: A retrospective analysis from Wenzhou, southeast China.

Yuli Wang, Jisen Xue, Xinyue Dai...

https://pubmed.ncbi.nlm.nih.gov/29851256

Treatment of HPV Infection-Associated Low Grade Cervical Intraepithelial Neoplasia with 5-Aminolevulinic Acid-Mediated Photodynamic Therapy.

Daoyun Li, Fenghua Zhang, Lijuan Shi...

https://pubmed.ncbi.nlm.nih.gov/32835877

Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection.

Xiaoyun Wang, Lifang You, Weijiang Zhang...

https://pubmed.ncbi.nlm.nih.gov/35288319