NCT02849860已完成1 期
A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-121 Lotion in Subjects With 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
- 20
- 试验地点
- 2
- 主要终点
- Evaluators Global Severity Score at Day 15
研究概览
简要总结
Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.
详细描述
Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between the ages of 9 and <17 years (16 years 11 months inclusive).
- •Written and oral informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
- •Subject must have a score of 3 (moderate) to 4 (severe) on the Evaluator's Global Severity Assessment at the screening and baseline visit in the facial area.
- •Subjects with facial acne inflammatory lesions 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 investigational drug or device within 30 days of enrollment or participation in research study or concurrent study with this study.
- •Any dermatological conditions on the face that could interfere with clinical evaluations acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinical significant rosacea, gram negative folliculitis.
- •Any underlying disease(s) 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 facial beard or mustache that could interfere with any study assessments.
研究组 & 干预措施
IDP-121 Lotion
Experimental
Lotion
干预措施: IDP-121 Lotion (Drug)
结局指标
主要结局
Evaluators Global Severity Score at Day 15
时间窗: 15 Days
Acne severity will be determined by the investigator/evaluator based on a global assessment of the inflammatory and non-inflammatory lesions of facial acne. 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 (2)
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