Bioequivalence of Two Halobetasol Propionate 0.05% Topical Ointments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 76
- 主要终点
- Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
研究概览
简要总结
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Demonstrated blanching response to Reference Drug
- •Weight within +/- 20% from normal for height and weight for body frame
- •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 systemic or topical corticosteroids
- •Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
- •Presence of medical condition requiring regular treatment with prescription drugs
- •Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
- •Use of any tobacco products in the 30 days prior to study dosing
- •Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
- •Receipt of any drugs as part of a research study within 30 days prior to study dosing
- •Pregnant or lactating
研究组 & 干预措施
Cohort Group 1
Subjects number 1 to 30
干预措施: Halobetasol Propionate 0.05% Ointment-Reference Product (Drug)
Cohort Group 1
Subjects number 1 to 30
干预措施: Halobetasol Propionate 0.05% Ointment-Test Product (Drug)
Cohort Group 2
Subjects number 31 to 56
干预措施: Halobetasol Propionate 0.05% Ointment-Reference Product (Drug)
Cohort Group 2
Subjects number 31 to 56
干预措施: Halobetasol Propionate 0.05% Ointment-Test Product (Drug)
Cohort Group 3
Subject Numbers 57 to 76
干预措施: Halobetasol Propionate 0.05% Ointment-Reference Product (Drug)
Cohort Group 3
Subject Numbers 57 to 76
干预措施: Halobetasol Propionate 0.05% Ointment-Test Product (Drug)
结局指标
主要结局
Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter
时间窗: Over the course of a day
次要结局
未报告次要终点