NCT02798419已完成2 期
Active-Controlled Study to Assess the Efficacy and Safety of DFD-05 in Subjects With Common Warts
Dr. Reddys Laboratories, SA12 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1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
- 50
- 试验地点
- 12
- 主要终点
- The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts)
研究概览
简要总结
DFD05 vs. Active01 in the treatment of common warts
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, any gender or race, must be in good general health as determined by the Investigator with a clinical diagnosis of common warts.
- •Subjects must have at least 1 visible, discrete, common wart with at least a 3 mm longitudinal diameter on the hands, feet (excluding soles) and palms (in that order of priority).
- •The warts must have been present for at least the past 12 weeks, but not more than 3 years
- •Subjects must agree to only use the study products and to not use any other wart-removing product (prescription, OTC or occlusion) during the course of the study.
- •Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.
- •Female subjects of childbearing potential must agree to use contraception during the study. All women of childbearing potential must have a negative urine pregnancy test at Screening and Baseline and at 4, 8 & 12 weeks visits.
- •Subjects are physically able to apply study product to all affected areas or can obtain help.
排除标准
- •Women who are pregnant or nursing or planning to become pregnant during the study.
- •Subjects who have been treated for warts within the 30 days prior to the Baseline Visit (e.g. salicylic acid, azelaic acid, cryotherapy).
- •Subjects who have participated in a trial involving any investigational product in the 30 days prior to the Baseline Visit.
- •Subjects with chronic or active liver disease, renal impairment, cutaneous or systemic lupus erythematosus, an autoimmune disorder, immunosuppression, or any other disease or medical condition that would interfere with the study or place the subject at unacceptable risk, as determined by the investigator.
- •Subjects on immunosuppressive agents that would impact their immune response e.g. cyclosporine, mycophenolate mofetil, azathioprine, etc.
- •Subjects who use or have used local/systemic steroids or any other immunosuppressive medication within the 30 days prior to the Baseline Visit.
- •Subjects who use or have used systemic or topical retinoids within the 30 days prior to the Baseline Visit.
- •Subjects who are unable to comply with study requirements.
- •Subjects with other skin diseases like molluscum contagiosum that may confound the evaluation of common warts.
- •Subjects who have received treatment for any type of cancer within 5 years of the Baseline Visit, except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
- •Subjects unable to comply with study requirements
研究组 & 干预措施
DFD05 Cream
Experimental
DFD05 Cream
干预措施: DFD05 Cream (Drug)
Active01 Cream
Active Comparator
Active01 Cream
干预措施: Active01 Cream (Drug)
结局指标
主要结局
The proportion of subjects categorized as treatment responders (defined as having at least 91% reduction in surface area, averaged across all target warts)
时间窗: Visit 5 (week 12)
次要结局
未报告次要终点
研究者
研究点 (12)
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