Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections
Conditions
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).
Interventions
Aminolaevulinic acid with illumination
DRUGPlacebo
Placebo with illumination
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 3 months after treatments | 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 | 3 months after treatments | Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV. |
| Clearance of high risk HPV | 3 months after treatments | Proportion of patients with high risk HPV clearance |
Countries
China
Outcome results
None listed