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RecruitingNCT06052033Updated May 13, 2025

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

An interventional study of CO2 in HPV-Related Cervical Carcinoma, Low-Grade Squamous Intraepithelial Lesions and HPV Infection, sponsored by First Affiliated Hospital of Wenzhou Medical University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by First Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • HPV-Related Cervical Carcinoma
  • Low-Grade Squamous Intraepithelial Lesions
  • HPV Infection
  • Photodynamic Therapy

Keywords

  • high-risk hpv infection
  • hpv persistent
  • Lsil
  • cervical lesions
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ALA-PDT Group

    PDT involves cervical gel application and 25-minute laser light exposure. The procedure is repeated three times.

    Procedure: CO2

  • 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

Interventions

  • ProcedureCO2

    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.

05

What researchers measure

Primary outcomes

  1. Regression of Cervical Lesions.

    Measure the rate of regression in cervical lesions after three PDT sessions.

    Time frame: Assessed at 6 months after the last PDT session.

Secondary outcomes

  1. Adverse Events.

    Monitor and document any adverse events or complications related to CO2 laser treatment.

    Time frame: Evaluated at 6 months after the CO2 laser treatment.

06

Study locations

1 of 1 sites recruiting
  • first affiliated hospital of Wenzhou medical university
    Wenzhou, Zhejiang 325015, China
    Recruiting
07

References and documents

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PubMed 33538338 ↗
  • Wang Y, Xue J, Dai X, Chen L, Li J, Wu Y, Hu Y. Distribution and role of high-risk human papillomavirus genotypes in women with cervical intraepithelial neoplasia: A retrospective analysis from Wenzhou, southeast China. Cancer Med. 2018 Jul;7(7):3492-3500. doi: 10.1002/cam4.1559. Epub 2018 May 30. PubMed 29851256 ↗
  • Yang Y, Meng YL, Duan SM, Zhan SB, Guan RL, Yue TF, Kong LH, Zhou L, Deng LH, Huang C, Wang S, Wang GY, Wu DF, Zhang CF, Chen F. REBACIN(R) as a noninvasive clinical intervention for high-risk human papillomavirus persistent infection. Int J Cancer. 2019 Nov 15;145(10):2712-2719. doi: 10.1002/ijc.32344. Epub 2019 Apr 29. PubMed 30989655 ↗
  • Crosbie EJ, Einstein MH, Franceschi S, Kitchener HC. Human papillomavirus and cervical cancer. Lancet. 2013 Sep 7;382(9895):889-99. doi: 10.1016/S0140-6736(13)60022-7. Epub 2013 Apr 23. PubMed 23618600 ↗
  • Fu Y, Bao Y, Hui Y, Gao X, Yang M, Chang J. Topical photodynamic therapy with 5-aminolevulinic acid for cervical high-risk HPV infection. Photodiagnosis Photodyn Ther. 2016 Mar;13:29-33. doi: 10.1016/j.pdpdt.2015.12.004. Epub 2015 Dec 10. PubMed 26687616 ↗
  • Bhowmick R, Girotti AW. Signaling events in apoptotic photokilling of 5-aminolevulinic acid-treated tumor cells: inhibitory effects of nitric oxide. Free Radic Biol Med. 2009 Sep 15;47(6):731-40. doi: 10.1016/j.freeradbiomed.2009.06.009. Epub 2009 Jun 11. PubMed 19524035 ↗
  • Hu Z, Li J, Liu H, Liu L, Jiang L, Zeng K. Treatment of latent or subclinical Genital HPV Infection with 5-aminolevulinic acid-based photodynamic therapy. Photodiagnosis Photodyn Ther. 2018 Sep;23:362-364. doi: 10.1016/j.pdpdt.2018.07.014. Epub 2018 Jul 23. PubMed 30048762 ↗
  • Li D, Zhang F, Shi L, Lin L, Cai Q, Xu Y. Treatment of HPV Infection-Associated Low Grade Cervical Intraepithelial Neoplasia with 5-Aminolevulinic Acid-Mediated Photodynamic Therapy. Photodiagnosis Photodyn Ther. 2020 Dec;32:101974. doi: 10.1016/j.pdpdt.2020.101974. Epub 2020 Aug 21. PubMed 32835877 ↗
  • Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.1016/j.pdpdt.2022.102807. Epub 2022 Mar 11. PubMed 35288319 ↗
  • Navarro Santana B, Sanz Baro R, Orozco R, Plaza Arranz J. Cervical vaporization in LSIL and persistent HPV infection. Taiwan J Obstet Gynecol. 2018 Aug;57(4):475-478. doi: 10.1016/j.tjog.2018.06.010. PubMed 30122563 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06052033
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Responsible party
YANHU (director, First Affiliated Hospital of Wenzhou Medical University) — Principal investigator
First posted
Sep 25, 2023
Start date
Sep 11, 2023
Primary completion
Aug 10, 2024
Completion
Jun 30, 2025 (estimated)
Last update
May 13, 2025

Study contacts

YAN HU, PHD
Contact
627830566@qq.com
008613806696807
kowthar mohamed shaie, master
Contact
milgo1995@hotmail.com
008615542452638

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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