drugset / Trial / NCT05114226
A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study was a single-center prospective phase I clinical study to evaluate the effectiveness and safety of BH4 in the treatment of radiation-induced skin injury during vulvar cancer radiotherapy.
Timeline
- Start
- 2022-03-01
- Primary completion
- 2023-11-01
- Completion
- 2024-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sapropterin | Unknown | 50 ug/ml | Topical |
| Subject | sapropterin | Unknown | 100 ug/ml | Topical |
| Subject | sapropterin | Unknown | 200 ug/ml | Topical |
| Subject | sapropterin | Unknown | 400 ug/ml | Topical |
| Subject | sapropterin | Unknown | 600 ug/ml | Topical |
| Subject | sapropterin | Unknown | 800 ug/ml | Topical |
| Subject | sapropterin | Unknown | 1000 ug/ml | Topical |