NCT02377999已完成2 期
Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
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
- LEO Pharma
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of incidence and severity of Local Skin Reactions (LSR)
研究概览
简要总结
An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.
详细描述
The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.
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
- •A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:
- •In both sexes: inguinal, perineal, and perianal areas
- •In men: penis shaft, scrotum, glans penis and foreskin
- •In women: on the vulva
- •Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
- •Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
排除标准
- •Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
- •Subject suffer from any of the following conditions:
- •Known human immunodeficiency virus (HIV) infection
- •An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
- •Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
- •Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
- •Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
- •Prior quadrivalent HPV vaccination
研究组 & 干预措施
Treatment of genetial warts with Picato
Experimental
干预措施: Picato (Drug)
结局指标
主要结局
Number of incidence and severity of Local Skin Reactions (LSR)
时间窗: Measured two weeks after every treatment and final measurement 2 weeks after last treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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