NCT01214564已完成2 期
A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations
Peplin2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
研究概览
简要总结
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Up to three days of treatment
干预措施: PEP005 (ingenol mebutate) Gel (Drug)
结局指标
主要结局
To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
时间窗: Day 43
次要结局
- To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.(Day 43)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or ExtremitiesSuperficial Basal Cell CarcinomaNCT01325688Peplin75
已完成
3 期
Eltrombopag Phase III Study In Chinese Chronic ITP PatientsPurpura, Thrombocytopenic, Idiopathic and Hepatitis CNCT01762761Novartis Pharmaceuticals155
已完成
1 期
A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic MalignanciesMalignant Melanoma, NeoplasmsNCT01844674Hoffmann-La Roche18
终止
2 期
A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic MelanomaUnresectable MelanomaMetastatic MelanomaCancerCancer of SkinMelanoma (Skin)MelanomaNCT04337931Apexigen America, Inc.45
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)Locally Advanced or Metastatic Breast CancerNCT05296798Hoffmann-La Roche922