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

• Status: Completed
• Trial end date: 2018-11-24
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
• Treatments: Aminolevulinic Acid

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