Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Incidence of treatment-related Adverse Events associated with Fespixon cream
研究概览
简要总结
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
详细描述
This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds.
At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pressure Injury in Sacrum and Greater Trochanter Wound
- Name: Fespixon Cream
- Dosage form: Topical cream, 15 g ointment per tube
- Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%)
- Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness)
- Dosing schedule: Apply once a day
- Duration: up to 16 weeks
干预措施: Fespixon Cream (Drug)
结局指标
主要结局
Incidence of treatment-related Adverse Events associated with Fespixon cream
时间窗: 16 weeks
Note: * Assessment of Safety: Safety will be assessed based on the incidence of adverse events, including overall AEs, Fespixon-related AEs, target pressure ulcer-related AEs, and SAEs. * During the trial, in addition to self-reported AEs, physicians will check physical examination, vital signs, and laboratory reports to determine the presence of AEs.
次要结局
- Incidence of complete wound closure of the target ulcer area(16 weeks)
- Time to complete wound closure of the target ulcer area(16 weeks)
- Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline)(16 weeks)
研究者
Hsian-Jenn Wang
Consultant, Department of Surgery
Taipei Medical University WanFang Hospital