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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Aminolaevulinic acid with illumination
Placebo with illumination
Peking University People's Hospital
Beijing, Beijing Municipality, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Response rate
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.
Time frame: 3 months after treatments
Complete response rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Time frame: 3 months after treatments
Clearance of high risk HPV
Proportion of patients with high risk HPV clearance
Time frame: 3 months after treatments
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