Clinical trial · Interventional
Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
NCT02631863CI-TRIAL-00039375completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Low-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolaevulinic acid | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALA
- description
- Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
- interventionNames
- Drug: Aminolaevulinic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will receive 3 topical treatments of placebo 500mg
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- Response rate
- timeFrame
- 3 months after treatments
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.