A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 13
- 主要终点
- Safety and tolerability (incidence of AEs, SAEs and skin responses)
研究概览
简要总结
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be male and at least 18 years of age.
- •A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
排除标准
- •Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
- •Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- •Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
研究组 & 干预措施
1
Cohort 1 One 25 cm2 treatment area; on one arm
干预措施: PEP005 Topical gel (Drug)
2
Cohort 2 One 50cm2 contiguous treatment area; on one arm
干预措施: PEP005 Topical gel (Drug)
3
Cohort 3 Two 25cm2 treatment areas; one on each arm
干预措施: PEP005 Topical gel (Drug)
4
Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm
干预措施: PEP005 Topical gel (Drug)
5
Cohort 5 One 75cm2 contiguous treatment area; on one arm
干预措施: PEP005 Topical gel (Drug)
6
Cohort 6 Two 50cm2 contiguous treatment area; one on each arm
干预措施: PEP005 Topical gel (Drug)
7
Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm
干预措施: PEP005 Topical gel (Drug)
8
Cohort 8 One 100cm2 contiguous treatment area; on one arm
干预措施: PEP005 Topical gel (Drug)
结局指标
主要结局
Safety and tolerability (incidence of AEs, SAEs and skin responses)
时间窗: Screening to End of Study (Day 57)
次要结局
未报告次要终点