A Phase 1, Two-stage, Single-centre, Open Label, Within- and Between-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Subjects With Actinic Keratosis on the Upper Extrem-ity. A Single-arm First Stage Followed by a Two-arm, Parallel Group, Randomized, Placebo (Vehicle) -Controlled Second Stage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Degree of Infiltration
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 reflectance confocal microscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 subjects at least 18 years of age
- •Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity
- •Subjects must have a 25 cm2 area of normal skin on the inner upper arm
- •Female subjects must be of either:• Non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • Childbearing potential, with a confirmed negative urine pregnancy test prior to exposure.
- •Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
- •Ability to follow trial instructions and likely to complete all trial requirements
- •Obtained written informed consent prior to any trial-related procedures
排除标准
- •Location of the selected treatment areas:• Within 5 cm of an incompletely healed wound or infected area of the skin • Within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma(SCC)
- •History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product
- •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 during the course of the trial, as determined by Investigator clinical judgment
- •Anticipated need for in-patient hospitalisation or in-patient surgery during the trial 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
- •Previous enrolment in this clinical trial
- •Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2 cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of acid-containing therapeutic products • Use of topical salves or topical steroids
- •Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit: • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with UVB
- •Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit: • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas.
- •Use of systemic retinoids
研究组 & 干预措施
PEP005 Gel 0.05%
active ingredient of PEP005: Ingenol mebutate
干预措施: Ingenol mebutate (Drug)
Placebo Gel
Vehicle of PEP005 Gel
干预措施: Placebo Gel (Drug)
结局指标
主要结局
Change in Degree of Infiltration
时间窗: Baseline to Day 57
Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin The degree of infiltration of the epidermis by inflammatory cells will be based on "inflammation/small bright cells" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on "inflammatory cells in the dermis" (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel.
Change in Degree of Necrosis
时间窗: Baseline to Day 57
Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin
次要结局
未报告次要终点