ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

May 31, 2021

Primary Completion Date

December 20, 2023

Study Completion Date

March 6, 2024

Conditions
Cervical Intraepithelial Neoplasia Grade 2Papillomavirus Infectionsp16 Protein
Interventions
DRUG

Aminolaevulinic acid (500-mg bottle)

once a week for 6 weeks

DRUG

Aminolaevulinic acid (750-mg bottle)

once a week for 6 weeks

DRUG

Placebo

once a week for 6 weeks

Trial Locations (5)

100191

Peking University Third Hospital, Beijing

200011

The Obstetrics & Gynecology Hospital of Fudan University, Shanghai

200120

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

250012

Qilu Hospital of Shandong University, Jinan

450000

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY