Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)
研究概览
简要总结
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel
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
- Double (Participant, Investigator)
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 contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities
排除标准
- •Location of the treatment area (trunk (except chest) or extremities)
- •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 within the selected treatment area
- •Lesions in the treatment area 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
4 days placebo
Placebo
干预措施: Placebo (Other)
4 days drug
Drug
干预措施: ingenol mebutate (Drug)
1 day placebo and 3 days drug
Placebo and drug
干预措施: Placebo (Other)
2 days placebo and 2 days drug
Placebo and drug
干预措施: ingenol mebutate (Drug)
2 days placebo and 2 days drug
Placebo and drug
干预措施: Placebo (Other)
1 day placebo and 3 days drug
Placebo and drug
干预措施: ingenol mebutate (Drug)
结局指标
主要结局
Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)
时间窗: At Week 8
Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in number of AKs. The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.
次要结局
- Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)(At Week 8)
- Percentage of Participants With Partial Clearance of AKs(At Week 8)