Clinical trial · Interventional
ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection
NCT06439433CI-TRIAL-00077666completedPhase 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)
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
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 Grade 2 | — | UNRESOLVED | — |
| p16 Protein | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolaevulinic acid (500-mg bottle) | Drug | — | UNRESOLVED |
| Aminolaevulinic acid (750-mg bottle) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ALA A Group
- description
- ALA 500mg Group
- interventionNames
- Drug: Aminolaevulinic acid (500-mg bottle)
- type
- EXPERIMENTAL
- label
- ALA B Group
- description
- ALA 750mg Group
- interventionNames
- Drug: Aminolaevulinic acid (750-mg bottle)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Group
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women, 18-45 years of age * Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months * Intense desire to retain the cervical structure or function * High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months * 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 * Signed written informed consent Exclusion Criteria: * Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) 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 wall * Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination * Undiagnosed vaginal bleeding within the last 3 months * 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 or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years * Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN) * History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months * Pregnancy or nursing * Participation in any clinical studies within the last 30 days * Poor compliance or inability to complete the trial * 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.