Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2 (PDT for CIN2)

December 14, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Women's Hospital School of Medicine Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • First People's Hospital of Hangzhou
        • Contact:
      • Hangzhou, Zhejiang, China
      • Ningbo, Zhejiang, China
        • First Affiliated Hospital of Ningbo University
        • Contact:
      • Shaoxing, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female, 25-60 years, understands study procedures and consents to participate;
  2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
  3. Provides written informed consent.

Exclusion Criteria:

  1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
  2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
  3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
  4. Undiagnosed vaginal bleeding;
  5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
  6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
  7. Pregnant or breastfeeding women;
  8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);
  9. Use of interferon or antiviral therapy within 3 months;
  10. Any other condition deemed unsuitable for participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALA-PDT Group
ALA-PDT treatment for cervical lesions 6 to 9 times
Procedure: ALA-PDT
Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
Active Comparator: LEEP Group
LEEP surgery for cervical lesions
Procedure: LEEP surgery
After anesthesia, cervical iodine staining was performed, followed by LEEP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion effective rate
Time Frame: 6 months
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion effective rate
Time Frame: 2 years
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment.
2 years
HPV clearance rate
Time Frame: 2 years
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
2 years
Lesion cure rate
Time Frame: 2 years
Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on cervical anatomy and function
Time Frame: 2 years
Cervical length and function before and after treatment, and subsequent pregnancy outcomes in patients desiring fertility.
2 years
Adverse events
Time Frame: 2 years
Record post-treatment adverse events including bleeding, infection, and pain.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

First People's Hospital of Hangzhou
Women's Hospital School Of Medicine Zhejiang University
Shaoxing People's Hospital
Linping First People's Hospital
First Affiliated Hospital of Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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