NCT02547233已完成3 期
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 437
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
研究概览
简要总结
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.
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
- •Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
- •Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area
排除标准
- •Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
- •Treatment with ingenol mebutate gel in the treatment area within the last 12 months
- •Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
- •History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
研究组 & 干预措施
LEO 43204 gel
Experimental
Treatment once daily for 3 days
干预措施: LEO 43204 gel (Drug)
Vehicle gel
Placebo Comparator
Treatment once daily for 3 days
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
时间窗: At Week 8
Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area. The table shows the percentage of mean number of subjects across imputations with complete clearance.
次要结局
- Percentage of Participants With Partial Clearance (Multiple Imputation)(At Week 4)
- Percent Reduction in AK Count in the Treatment Area Compared to Baseline(At Week 8)
研究者
研究点 (1)
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