EUCTR2005-001593-26-DE进行中（未招募）1 期
Topical treatment of verrucae vulgares with Verrumal® in organtransplant recipients (OTR) – prospective, double-blind, placebo-controlled randomised trial - Verrumal in verrucae vulgares (OTRs)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •·Given written informed consent
- •·Men or women aged 18 or over
- •·Diagnosis of verrucae vulgaris with a minimum duration of 3 months
- •·Organ transplant recipients for a minimum of 2 years
- •·Women are required to use a reliable method of contraception or
- •are postmenopausal
- •·Existence of a minimum of 5 warts – located on hands and forearms
- •·Patient is willing and able to participate in the study as an outpatient, make frequent visits to the clinic, and comply with all study requirements, including the following:
- •oclinic visits during the prestudy, treatment, and follow-up period
- •oapplication of study medication (Verrumal® solution, placebo solution)
- •opre-treatment curettage for virus typing, blood sample and eyebrow hairs
- •opost-treatment curettage for virus typing
- •opregnancy testing for females of childbearing potential
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Known allergic or hypersensitive reactions to components of the study medication
- •·Diagnosis of subungual or periungal warts in the treatment area,
- •·Warts treatment within the previous 3 months before inclusion
- •·Area to be treated exceeds 25 cm²
- •·Patient is taking any medication which could interfere with the study drug and could influence interactions; e.g Methotraxate, Sulfonylurea, Salicylic acid, Dihydropyrimidindehydrogenase-(DPDH)-Inhibitor, Brivudin, systemic 5-FU
- •·Renal failure (creatinine > 6mg/dl)
- •·Serious illness within the previous 4 weeks or life-threatining diseases
- •·Pregnancy or nursing (lactation)
- •·Participation in another clinical trial in the month preceding the study
- •·Patient has a severe illness or psychiatric condition on account of which the patient should not participate in the study in the opinion of the investigator
- •·Patient is suffering from active chemical dependency or alcoholism, as assessed by the investigator.
- •·Maximum of 10 warts in the treatment area
研究者
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