NCT01135069已完成3 期
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
Spear Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Improvement in Acne
研究概览
简要总结
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
详细描述
Not required
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy male and female children and adult
- •Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
- •Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
- •Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
- •Considered reliable and capable of understanding their responsibility and role in the study.
排除标准
- •Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
- •Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
- •Use topical acne therapy during the two week period prior to study initiation.
- •Use of systemic retinoid treatment within six months prior to study initiation.
- •Pregnant or breast-feeding.
- •Serious psychological illness.
- •Participation in any clinical research study during the 30 day period preceding study initiation.
研究组 & 干预措施
Generic
Active Comparator
treatment of acne for 12 weeks
干预措施: Tretinoin microsphere 0.1% (Drug)
Brand
Active Comparator
Treatment of acne for 12 weeks
干预措施: Brand Retin-A Micro tretinoin microsphere gel 0.1% (Drug)
Placebo
Placebo Comparator
Treatment if acne for 12 weeks as placebo
干预措施: placebo microsphere gel (Drug)
结局指标
主要结局
Improvement in Acne
时间窗: 12 weeks
Counting of acne lesions both inflammatory and non-inflammatory
次要结局
未报告次要终点
研究者
研究点 (1)
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