Trials / Completed
CompletedNCT06439433
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aminolaevulinic acid (500-mg bottle) | once a week for 6 weeks |
| DRUG | Aminolaevulinic acid (750-mg bottle) | once a week for 6 weeks |
| DRUG | Placebo | once a week for 6 weeks |
Timeline
- Start date
- 2021-05-31
- Primary completion
- 2023-12-20
- Completion
- 2024-03-06
- First posted
- 2024-06-03
- Last updated
- 2024-06-03
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06439433. Inclusion in this directory is not an endorsement.