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)
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Condition
Cervical Intraepithelial Neoplasia
Intervention
Aminolaevulinic acid
Study Arms / Comparison Groups
ALA
Description: Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
March 22, 2016
Completion Date
November 24, 2018
Primary Completion Date
November 24, 2018
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
Gender
Female
Ages
25 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Beihua Kong, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02631863
Organization ID
FDZJALA-201510
Responsible Party
Sponsor
Study Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study Sponsor
Beihua Kong, MD, Principal Investigator, Qilu Hospital of Shandong University
Verification Date
July 2019