NCT02667275已完成3 期
A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
研究概览
简要总结
This is a randomized, double-blind, vehicle-controlled, parallel group study.
详细描述
This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.
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
- •Subject is at least 18 years of age
- •Clinical diagnosis of stable clinically typical seborrheic keratosis
- •Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
- •Have a clinically typical appearance
- •Have a PLA of 2 or greater and be a discrete lesion
- •Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
- •Not be in an intertriginous fold
- •Not be on the eyelids
- •Not be within 5mm of the orbital rim
- •Not be pedunculated
- •If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees 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 evaluation of any Target Lesion 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
- •Subject is able to comprehend and willing to sign an Informed Consent Form.
排除标准
- •Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions
- •Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat)
- •Subject has a current systemic malignancy
- •Subject has used any of the following systemic therapies within the specified period prior to enrollment:
- •Retinoids; 180 days
- •Glucocortico-steroids;
- •Anti-metabolites (e.g., methotrexate);
- •Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
- •LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy;
- •Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate;
- •Retinoids;
- •Microdermabrasion or superficial chemical peels;
- •Glucocortico-steroids or antibiotics
- •Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
- •A cutaneous malignancy;
- •A sunburn; currently
- •A pre-malignancy (e.g., actinic keratosis); currently
- •Body art (e.g., tattoos, piercing, etc.); currently
- •Excessive tan; currently
- •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, etc.), 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
- •Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
研究组 & 干预措施
A-101 Solution
Experimental
A-101 Solution 40% administered once
干预措施: A-101 Solution (Drug)
Vehicle Solution
Placebo Comparator
Vehicle Solution administered once
干预措施: Vehicle Solution (Other)
结局指标
主要结局
Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
时间窗: Study day 106
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
次要结局
- Percent of Lesions Cleared Scale(Study day 106)
研究者
研究点 (1)
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