NCT01387711已完成1 期
A Phase I, Single-centre, Open Label, Within-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Patients With Actinic Keratosis on the Upper Extremity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
研究概览
简要总结
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients at least 18 years of age
- •Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
- •Patients with a 25 cm2 area of normal skin on the upper inner arm
- •Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
- •Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
- •Ability to follow study instructions and likely to complete all study requirements
- •Obtained written informed consent prior to any study-related procedures
排除标准
- •Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- •History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
- •Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
- •Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
- •Current participation in any other interventional clinical trial
- •Subjects who have received treatment with any non-marketed drug product within the last two months
- •Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
- •Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
- •Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- •Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- •Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- •Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
- •Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
- •Use of systemic retinoids
研究组 & 干预措施
ingenol mebutate
Experimental
PEP gel 0.05% once daily exposure
干预措施: PEP005 (Ingenol mebutat Gel, 0.05 %) (Drug)
结局指标
主要结局
Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
时间窗: From baseline until day 3
Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3
次要结局
- Biological effects in the skin(from baseline till day day 3)
研究者
研究点 (1)
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