Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp 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
- 220
- 试验地点
- 1
- 主要终点
- Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
研究概览
简要总结
To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate 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 full balding scalp.
- •Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp
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
Part 1: LEO 43204
Open-label, dose escalation, 2 days treatment
干预措施: LEO 43204 (Drug)
Part 2: LEO 43204 x dose
X dose for 2 days treatment
干预措施: LEO 43204 (Drug)
Part 2: LEO 43204 Y dose
Y dose for 2 days treatment
干预措施: LEO 43204 (Drug)
Part 2: Placebo
Placebo for 2 days treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
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) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT. A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT. The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are 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) Lesion Count
时间窗: From baseline to Week 8
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.
次要结局
- Part 2: Participants With Complete Clearance of AKs(From baseline to Week 8)
- Part 2: Participants With Partial Clearance of AKs(From baseline to Week 8)