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

NCT02631863 | Completed Phase 2

• 1 other identifier: FDZJALA-201510
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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).

Conditions

Cervical Intraepithelial Neoplasia; Low-Grade Squamous Intraepithelial Lesions; Papillomavirus Infections

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

ALA

EXPERIMENTAL

Patients will receive 3 topical treatments of aminolaevulinic acid 500mg

Drug: Aminolaevulinic acid

Placebo

PLACEBO COMPARATOR

Patients will receive 3 topical treatments of placebo 500mg

Drug: Placebo

Interventions

Aminolaevulinic acid DRUG

Aminolaevulinic acid with illumination

ALA

Placebo DRUG

Placebo with illumination

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions; Papillomavirus Infections

Interventions

5-aminolaevulinic acid-n-pentylester

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes

Study Officials

• Beihua Kong, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Youzhong Zhang, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Jining Tao

  Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 16, 2015
• Study Start: March 22, 2016
• Primary Completion: November 24, 2018
• Study Completion: November 24, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CN (4)