NCT02849873已完成1 期
Randomized Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-123 Lotion in Comparison With Tazorac Cream in Subjects With Moderate to Severe Acne Vulgaris Under Maximal Use Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne.
研究概览
简要总结
The Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison with Tazorac Cream.
详细描述
Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under maximal use conditions.
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
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).
- •Verbal and written informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if the subject reaches age of consent during the study they should be re-consented at the next study visit).
- •Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the screening and baseline visit.
- •Subjects with facial acne inflammatory lesion count no less than 20 but no more than
- •Subjects with facial acne non-inflammatory lesions count no less than 20 but no more than
排除标准
- •Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- •Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema.
- •Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- •Subjects with a facial beard or mustache that could interfere with the study assessments.
- •Subjects with more than 2 facial nodules.
研究组 & 干预措施
IDp-123 Lotion
Experimental
Lotion
干预措施: IDP-123 Lotion (Drug)
Tazorac Cream
Active Comparator
Cream
干预措施: Tazorac Cream (Drug)
结局指标
主要结局
Evaluator's Global Severity Score: At Day 15 (or ET), acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne.
时间窗: 15 Days
Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe)
次要结局
未报告次要终点
研究者
研究点 (1)
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