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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631863
• Other study ID #: FDZJALA-201510
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2016
• Est. completion date: November 24, 2018

Study information

• Verified date: July 2019
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 24, 2018
• Est. primary completion date: November 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Low-Grade Squamous Intraepithelial Lesions
• Neoplasms
• Papillomavirus Infections
• Squamous Intraepithelial Lesions of the Cervix
• Uterine Cervical Dysplasia

Intervention

Drug:
• Aminolaevulinic acid
Aminolaevulinic acid with illumination
• Placebo
Placebo with illumination

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clearance of high risk HPV	Proportion of patients with high risk HPV clearance	3 months after treatments