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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-22

Study Completion Date

2018-11-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia Low-Grade Squamous Intraepithelial Lesions Papillomavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALA

Patients will receive 3 topical treatments of aminolaevulinic acid 500mg

Group Type EXPERIMENTAL

Aminolaevulinic acid

Intervention Type DRUG

Aminolaevulinic acid with illumination

Placebo

Patients will receive 3 topical treatments of placebo 500mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo with illumination

Interventions

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Aminolaevulinic acid

Aminolaevulinic acid with illumination

Intervention Type DRUG

Placebo

Placebo with illumination

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No