NCT03487588已完成4 期
An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Subject Satisfaction
研究概览
简要总结
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject can comprehend and is willing to sign an informed consent for participation in this study.
- •Male or female between the ages of 30 and 75 years old.
- •Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.
- •Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
- •Target and non-target SKs must not have been previously treated.
- •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 or non-target SK or which exposes the subject to an unacceptable risk by study participation
排除标准
- •Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
- •Subject has current systemic malignancy.
- •Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.
- •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
研究组 & 干预措施
A-101 Topical Solution
Experimental
Open Label Arm
干预措施: A-101 Topical Solution (Drug)
结局指标
主要结局
Subject Satisfaction
时间窗: Day 113
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
次要结局
- Effectiveness of Treatment(Day 113)
- Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction(Day 113)
研究者
研究点 (1)
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