drugset / Trial / NCT05114226

A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury

NCT05114226

Phase 1 Unknown 45 enrolled West China Second University Hospital
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

EvaluationDrugModalityDoseRoute
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

Indications