ClinicalTrials.gg
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

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Squamous Intraepithelial Lesions with a site in China — 17 open to participants now, 18 under way, none of them phase 3. Squamous Intraepithelial Lesions · China.

Planned enrollment
11th of 14
40 · median 153
Started
2023
with 2 others
No phase
7 of 26
6 open now
Primary completion
2024-08
later than 1 of 17 live
Registered
13th of 26
by date
Lead sponsor
1 of 26
First Affiliated Hospital of Wenzhou Medical University

Among the 26 studies in Squamous Intraepithelial Lesions with a site in China, this one is the 11th largest by planned enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2023, is one of 7 with no phase, reaches primary completion later than 1 of the 17 other live ones, and was the 13th registered.

Squamous Intraepithelial Lesions

103 studies on the registry are indexed under Squamous Intraepithelial Lesions; 35 are open to participants now.

Browse Squamous Intraepithelial Lesions studies →

Open to participants now

17 of the 26 studies in Squamous Intraepithelial Lesions with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 22 Squamous Intraepithelial Lesions studies recruiting now, 10 (45%) set no upper age limit and 11 (50%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Squamous Intraepithelial Lesions with a site in China, or all of them as a file.
02

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.

03

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
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 , antiviral agents, and .
  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 form.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

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.

06

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.

07

Study locations

1 of 1 sites recruiting
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Aug 2024, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2023
First posted
Sep 25, 2023
StartActual
Sep 11, 2023
Primary completionActual
Aug 10, 2024
CompletionEst.
Jun 30, 2025
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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