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

A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)

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).

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia; Papillomavirus Infections; Low-Grade Squamous Intraepithelial Lesions
• Intervention / Treatment: Drug: Aminolaevulinic acid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • The Obstetrics & Gynecology Hospital of Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Premenopausal women, 25-50 years of age
• Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
• Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
• Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
• Written informed consent signed

Exclusion Criteria:

• ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
• Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
• Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
• Undiagnosed vaginal bleeding
• With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
• With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors
• Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN)
• Pregnancy or nursing
• Previous physical therapy of LSIL/CIN1 after pathologic diagnosis
• Participation in any clinical studies within the last 30 days
• Subjects that the investigators judged to be not suitable to participate the study besides above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALA; Patients will receive 3 topical treatments of aminolaevulinic acid 500mg	Drug: Aminolaevulinic acid; Aminolaevulinic acid with illumination
Placebo Comparator: Placebo; Patients will receive 3 topical treatments of placebo 500mg	Drug: Placebo; Placebo with illumination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Based on histology, cytology and HPV status. "Response" is defined as: 1) pathology and cytology were both normal; 2) pathology and/or cytology showed low grade and the baseline HPV infection was cleared.	3 months after treatments
Complete response rate	Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.	3 months after treatments
Clearance of high risk HPV	Proportion of patients with high risk HPV clearance	3 months after treatments

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2016
• Primary Completion (Actual): November 24, 2018
• Study Completion (Actual): November 24, 2018

Study Registration Dates

• First Submitted: December 12, 2015
• First Submitted That Met QC Criteria: December 12, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Tumor Virus Infections; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Papillomavirus Infections
• Other Study ID Numbers: FDZJALA-201510