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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 24, 2018

Interventions

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

Arms, Groups and Cohorts

  • Experimental: ALA
    • Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
  • Placebo Comparator: Placebo
    • Patients will receive 3 topical treatments of placebo 500mg

Clinical Trial Outcome Measures

Primary Measures

  • Response rate
    • Time Frame: 3 months after treatments
    • 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.
  • Complete response rate
    • Time Frame: 3 months after treatments
    • Based on histology, cytology and HPV status. “Complete response” is defined as normal pathology, normal cytology and negative HPV.
  • Clearance of high risk HPV
    • Time Frame: 3 months after treatments
    • Proportion of patients with high risk HPV clearance

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beihua Kong, MD, Principal Investigator, Qilu Hospital of Shandong University
    • Youzhong Zhang, MD, Principal Investigator, Qilu Hospital of Shandong University
    • Jining Tao, Study Director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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