Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection (PDT for LSIL)

December 14, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical Low-grade Squamous Intraepithelial Lesions With HPV16/18 Infection

This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.

Study Type

Interventional

Enrollment (Estimated)

225

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 Contact Backup

  • Name: Jianwei Zhou, Professor

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:
          • Hongkai Shang, Doctor
          • Phone Number: 15990032799
      • Hangzhou, Zhejiang, China
        • Hangzhou Linping District first People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 310000
        • First Affiliated Hospital of Ningbo University
        • Contact:
      • Shaoxing, Zhejiang, China, 310000
        • Shaoxing People's Hospital
        • Contact:

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female, 20-60 years, understands study procedures and consents to participate;
  2. HPV 16 or 18 positive;
  3. Colposcopy-guided cervical biopsy within 3 months showing LSIL;
  4. 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 administered every 7-14 days for a total of 3-6 sessions.
Procedure: ALA-PDT
Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
No Intervention: Observation Group
Observation and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical lesion regression rate
Time Frame: 6 months
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV clearance rate
Time Frame: 2 years
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
2 years
Cervical lesion regression rate
Time Frame: 2 years
Proportion of patients with normal colposcopy-guided cervical biopsy histopathology, or NILM cytology plus negative HPV test, at 12 and 24 months.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 2 years
Record post-treatment bleeding, pain, and photosensitivity.
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 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

  • 2025-1380

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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