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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02631863
Other study ID # FDZJALA-201510
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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