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

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Cervical Intraepithelial Neoplasia

Papillomavirus Infections

Low-Grade Squamous Intraepithelial Lesions

Treatments

Drug: Placebo

Drug: Aminolaevulinic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02631863

FDZJALA-201510

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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