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

NCT06439433 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-06-03

No results posted yet for this study

Summary

Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2
  • Papillomavirus Infections
  • p16 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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2023-12-20
Completion
2024-03-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439433 on ClinicalTrials.gov