EUCTR2017-000228-85-GB进行中(未招募)1 期
Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis treated with ingenol disoxate gel 0.018% or 0.037%, or vehicle A phase 3 trial to compare the incidence of SCC and other skin neoplasia on skin areas treated with ingenol disoxate gel or vehicle gel for actinic keratosis on face and chest or scalp
EO Pharma A/S0 个研究点目标入组 563 人开始时间: 2017年4月10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
- 563
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
入选标准
- •The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at Visit 11 of that trial
- •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 625
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
排除标准
- •The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area
研究者
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Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis (sun spots) treated with ingenol disoxate gel or vehicleMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersActinic KeratosisEUCTR2017-000228-85-DEEO Pharma A/S850
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