A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like surface, are typically slightly raised above the surrounding skin and are generally diagnosed by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05% PEP005 Topical Gel.
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
- •Male and female patients at least 18 years of age.
- •A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand.
- •Written informed consent has been obtained.
- •Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.
排除标准
- 未提供
研究组 & 干预措施
1
Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.
干预措施: PEP005 (Drug)
结局指标
主要结局
Safety
次要结局
- Resolution of Common Wart(s)
