A Phase I/II, Two- Staged Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Nowarta110 in Patients With Plantar Warts and Clinical Recovery Successfully Completed
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Lesion Assessment
研究概览
简要总结
To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts
- Clinical Tolerance
- Clinical Recovery
- Evaluate Safety
详细描述
Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients with refractory or recurrent Plantar Warts.
- •No wart treatment for the last 12 weeks
- •Healthy male or non-pregnant, non-lactating female aged ≥ 18 years or greater
- •If female of childbearing potential, use an acceptable form of birth control during the study
- •Provide written informed consent or (HIPAA consent/authorization, as applicable
排除标准
- •Concurrent medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe
- •Female subjects who are breast-feeding or planning to become pregnant
- •Patients with a history of allergy to silver or fruits
- •Subjects with clinically significant unstable medical disorder, life threatening disease, or current malignancies
- •Subjects with History of Alcohol abuse or other drug abuse within 2 years prior to Randomization
- •Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment
- •Concomitant Medications: any other wart therapy is prohibited during the study.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Nowarta110 3 drops
Nowarta110 3 drops administration
干预措施: Nowarta110 (Drug)
Nowarta110 6 drops
Nowarta110 6 drops administration
干预措施: Nowarta110 (Drug)
Nowarta110 10 drops
Nowarta110 10 drops administration
干预措施: Nowarta110 (Drug)
结局指标
主要结局
Lesion Assessment
时间窗: 6 weeks
Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data
Incidence of Zero Lesion Measurement
时间窗: 6 weeks
Percent of participants with lesion measurement either equal to 0 or greater than 0
次要结局
未报告次要终点