NCT07306260

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• HSIL, High Grade Squamous Intraepithelial Lesion
• CIN 2
• HPV (Human Papillomavirus)-Associated
• Photodynamic Therapy (PDT)

Interventions

Type	Name	Description
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.
PROCEDURE	LEEP surgery	After anesthesia, cervical iodine staining was performed, followed by LEEP.

Timeline

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

Locations

5 sites across 1 country: China