Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
- Conditions
- Cervical Intraepithelial NeoplasiaLow-Grade Squamous Intraepithelial LesionsPapillomavirus Infections
- Interventions
- Drug: PlaceboDrug: Aminolaevulinic acid
- Registration Number
- NCT02631863
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients will receive 3 topical treatments of placebo 500mg ALA Aminolaevulinic acid Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
- Primary Outcome Measures
Name Time Method 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.
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.
Clearance of high risk HPV 3 months after treatments Proportion of patients with high risk HPV clearance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Women's Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking University People's Hospital🇨🇳Beijing, Beijing, China