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

NCT06052033 | Recruiting DMC

• 1 other identifier: KY2023-188
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

high-risk hpv infection; hpv persistent; Lsil; cervical lesions

Outcome Measures

Primary Outcomes (1)

• Regression of Cervical Lesions.

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

  Assessed at 6 months after the last PDT session.

Secondary Outcomes (1)

• Adverse Events.

  Evaluated at 6 months after the CO2 laser treatment.

Study Arms (2)

ALA-PDT Group

EXPERIMENTAL

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

Procedure: CO2

CO2 Laser Group

OTHER

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

CO2 PROCEDURE

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.

ALA-PDT Group; CO2 Laser Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years old with a history of sexual activity.
• 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).
• Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
• No fundamental diseases of important organs.
• Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
• There has been no history of using other drugs related to HPV infection in the past 3 months.

You may not qualify if:

• HR-HPV persistent infection.
• A total hysterectomy has been performed.
• Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
• Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
• Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
• Pregnant and lactating women.
• Acute reproductive tract inflammation.
• Diabetes patients with uncontrolled blood sugar.
• Patients who do not receive full treatment and follow-up.
• Those who fail to sign the informed consent form.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

first affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, 325015, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 33538338 RESULT

• 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.

  PMID: 29851256 RESULT

• 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.

  PMID: 30989655 RESULT

• 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.

  PMID: 23618600 RESULT

• 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.

  PMID: 26687616 RESULT

• 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.

  PMID: 19524035 RESULT

• 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.

  PMID: 30048762 RESULT

• 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.

  PMID: 32835877 RESULT

• 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.

  PMID: 35288319 RESULT

• 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.

  PMID: 30122563 RESULT

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes

Central Study Contacts

YAN HU, PHD

CONTACT

008613806696807; 627830566@qq.com

kowthar mohamed shaie, master

CONTACT

008615542452638; milgo1995@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: September 11, 2023
• Primary Completion: August 10, 2024
• Study Completion: June 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)