Trials / Completed
CompletedNCT04106258
A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hemoporfin PDT | Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients. |
Timeline
- Start date
- 2020-05-27
- Primary completion
- 2023-02-15
- Completion
- 2023-02-15
- First posted
- 2019-09-27
- Last updated
- 2023-12-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04106258. Inclusion in this directory is not an endorsement.