Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 224
- 试验地点
- 21
- 主要终点
- Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
研究概览
简要总结
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days
Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
- •Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk
排除标准
- •Location of the treatment area
- •within 5 cm of an incompletely healed wound
- •within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- •Prior treatment with ingenol mebutate gel on the treatment area
- •Lesions in the treatment areas that have:
- •atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
- •recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
研究组 & 干预措施
LEO 43204
Open-label, dose-escalation, 2-day treatment
干预措施: LEO 43204 (Drug)
LEO 43204 Dose 0.1%
LEO 43204 dose 0.1% once daily for two consecutive days
干预措施: LEO 43204 (Drug)
LEO 43204 Dose 0.075%
LEO 43204 dose 0.075% once daily for two days
干预措施: LEO 43204 (Drug)
Placebo
Placebo once daily for two days
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
时间窗: From Day 1 up to and including Day 8
The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT. A DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT. The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
时间窗: From baseline to Week 8
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.
次要结局
- Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])(From baseline to Week 8)
- Part 2: Participants With Partial Clearance of AKs (LOCF)(From baseline to Week 8)