NCT00864500已完成1 期
Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Vasoconstrictor Response
研究概览
简要总结
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
详细描述
Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.
Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
· Vasoconstrictor Response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
- •A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
- •A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
- •Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- •Signed and dated informed consent form which meets all criteria of current FDA regulations.
排除标准
- •History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
- •Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
- •Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
- •Presence of a medical condition requiring regular treatment with prescription drugs.
- •Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
- •Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
- •Use of any tobacco products in the 30 days prior to dosing.
- •Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
- •Pregnant or lactating.
研究组 & 干预措施
A
Experimental
Clobetasol Propionate 0.05% lotion, single exposure
干预措施: Clobetasol Propionate 0.05% lotion, single exposure (Drug)
B
Active Comparator
Clobex TM 0.05% Lotion, single exposure
干预措施: Clobex TM 0.05% Lotion, single exposure (Drug)
结局指标
主要结局
Vasoconstrictor Response
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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