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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Aminolaevulinic acid
Placebo
Sponsored by
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University People's Hospital
  • Qilu Hospital of Shandong University
  • The Obstetrics & Gynecology Hospital of Fudan University
  • Women's Hospital School of Medicine Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALA

Placebo

Arm Description

Patients will receive 3 topical treatments of aminolaevulinic acid 500mg

Patients will receive 3 topical treatments of placebo 500mg

Outcomes

Primary Outcome Measures

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.
Complete response rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Clearance of high risk HPV
Proportion of patients with high risk HPV clearance

Secondary Outcome Measures

Full Information

First Posted
December 12, 2015
Last Updated
July 5, 2019
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02631863
Brief Title
Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
Official Title
A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
November 24, 2018 (Actual)
Study Completion Date
November 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALA
Arm Type
Experimental
Arm Description
Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 3 topical treatments of placebo 500mg
Intervention Type
Drug
Intervention Name(s)
Aminolaevulinic acid
Intervention Description
Aminolaevulinic acid with illumination
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo with illumination
Primary Outcome Measure Information:
Title
Response rate
Description
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.
Time Frame
3 months after treatments
Title
Complete response rate
Description
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Time Frame
3 months after treatments
Title
Clearance of high risk HPV
Description
Proportion of patients with high risk HPV clearance
Time Frame
3 months after treatments

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beihua Kong, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youzhong Zhang, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jining Tao
Organizational Affiliation
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The Obstetrics & Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Women's Hospital School of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

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

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