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).
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
Description: Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
March 22, 2016
November 24, 2018
Primary Completion Date
November 24, 2018
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
25 Years - 50 Years
Accepts Healthy Volunteers
Beihua Kong, MD, ,
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Beihua Kong, MD, Principal Investigator, Qilu Hospital of Shandong University