EUCTR2015-002450-12-DE进行中（未招募）1 期
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest including 12-month follow-upPart 1: 3-day treatment period including an 8-week follow-up periodPart 2: extended 12-month follow-up periodA phase 3, multi-centre, randomised, parallel group, double-blind, vehicle-controlled trial - N/A
EO Pharma A/S0 个研究点目标入组 306 人开始时间: 2015年10月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 306
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the face or chest
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 153
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 153
排除标准
- •-Location of the treatment area (full face or chest)
- •within 5 cm of an incompletely healed wound
- •within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (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. hypertrophic, hyperkeratotic or cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
研究者
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