Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia

Inclusion criteria

• Premenopausal women, 25-50 years of age
• Meet one of the 3 following conditions:

high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function

• Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
• In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
• 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

• Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
• Invasive carcinoma possibility or positive endocervical curettage 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 similar compounds
• Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
• Pregnancy or nursing
• Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
• 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