A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Physician's Wart Assessment
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
详细描述
The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- •Male or female ≥ 8 years old.
- •Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
- •Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
- •Subject is non-pregnant and non-lactating.
- •Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
- •Subject is willing and able to follow all study instructions and to attend all study visits.
排除标准
- •Subject has clinically atypical warts on the trunk or extremities.
- •Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- •Subject has a history of Human Immunodeficiency Virus (HIV) infection
- •Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
- •Subject has a history of sensitivity to any of the ingredients in the study medications.
- •Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
- •Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
研究组 & 干预措施
Active
A-101 Topical Solutions
干预措施: A-101 Topical Solution (Drug)
Vehicle
Vehicle
干预措施: A-101 Vehicle Solution (Drug)
结局指标
主要结局
Physician's Wart Assessment
时间窗: Day 57
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)
次要结局
未报告次要终点