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Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)

NCT02631863 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-08

No results posted yet for this study

Summary

This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).

Conditions

  • Cervical Intraepithelial Neoplasia
  • Low-Grade Squamous Intraepithelial Lesions
  • Papillomavirus Infections

Interventions

DRUG

Aminolaevulinic acid

Aminolaevulinic acid with illumination

DRUG

Placebo

Placebo with illumination

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Beihua Kong, MD · Qilu Hospital of Shandong University

  • Youzhong Zhang, MD · Qilu Hospital of Shandong University

  • Jining Tao · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2018-11-24
Completion
2018-11-24

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 NCT02631863 on ClinicalTrials.gov