NCT07306247

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• HPV-16/18
• Photodynamic Therapy (PDT)
• LSIL, Low Grade Squamous Intraepithelial Lesion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2027-12-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

5 sites across 1 country: China