Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.
研究概览
简要总结
Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Diagnosed with sun-damaged skin on the face and AK in the treatment area
- •Willing and able to comply with all study procedures
- •Use of medically acceptable contraception in males or females of child-bearing potential
- •51 -100 years of age
- •Negative pregnancy test at baseline in females of childbearing potential
排除标准
- •Allergy or intolerance towards the active ingredient or any of the constituents of the IMP
- •Any contraindication for the IMP, according to the most recent version of the SmPC
- •Open lesions of any kind on the face
- •Concomitant cutaneous malignancy in treatment area, including but not restricted to squamous skin cancer
- •Immune deficiency
- •Participation in another clinical trial during the last six months
- •Pregnancy or lactation
研究组 & 干预措施
Treatment
干预措施: Tirbanibulin (Drug)
结局指标
主要结局
Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin.
时间窗: 57± 7 days
Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment.
次要结局
未报告次要终点