Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
研究概览
简要总结
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- •The full face
- •The full balding scalp
- •A contiguous area of approximately 250 cm2 on trunk or extremities
排除标准
- •Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
- •Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
- •Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months
- •Lesions in the treatment area that have: atypical clinical appearance (e.g. 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, 0.018% once daily for 3 days
干预措施: LEO 43204 (Drug)
LEO 43204, 0.037% once daily for 3 days
干预措施: LEO 43204 (Drug)
LEO 43204, 0.1% once daily for 3 days
干预措施: LEO 43204 (Drug)
结局指标
主要结局
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
时间窗: 8 days / From baseline (Day 1) to Day 8
For face/chest, 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: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities 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 four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
次要结局
- Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic(4 weeks and 8 weeks / From baseline to Week 4, and Week 8)
- Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic(4 weeks and 8 weeks / From baseline to Week 4, and Week 8)
- Percentage of Participants With Complete Clearance of AKs(8 weeks)