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

Study Overview
=================
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).

Official Title
-----------------
A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)

Conditions
-----------------
Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections

Intervention / Treatment
-----------------
* Drug: Aminolaevulinic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA<br>Patients will receive 3 topical treatments of aminolaevulinic acid 500mg | Drug: Aminolaevulinic acid<br>* Aminolaevulinic acid with illumination<br>|
| Placebo Comparator: Placebo<br>Patients will receive 3 topical treatments of placebo 500mg | Drug: Placebo<br>* Placebo with illumination<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months after treatments | 
| Clearance of high risk HPV | Proportion of patients with high risk HPV clearance | 3 months after treatments |