NCT02361216已完成3 期
Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest
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
- 729
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
研究概览
简要总结
The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
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
- 是
入选标准
- •Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic 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 the chest
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 squamous cell carcinoma (SCC).
- •Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
- •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 horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
研究组 & 干预措施
Ingenol mebutate gel
Experimental
Treatment once daily for 3 days
干预措施: Ingenol Mebutate (Drug)
Vehicle
Placebo Comparator
Treatment once daily for 3 days
干预措施: Vehicle (Other)
结局指标
主要结局
Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
时间窗: 8 weeks
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
次要结局
- Percentage of Participants With Partial Clearance at Week 4(4 weeks)
- Percent Reduction From Baseline in AK Count(8 weeks)
- Percentage of Participants With Partial Clearance at Week 8(8 weeks)
研究者
研究点 (1)
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Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.Actinic keratosis on the face or scalpMedDRA version: 18.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-003218-98-DEEO Pharma A/S500
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Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.Actinic keratosis on the face or scalpMedDRA version: 17.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-003218-98-GBEO Pharma A/S502
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Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.EUCTR2014-003218-98-ESEO Pharma A/S500