Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma Minocycline Level
研究概览
简要总结
The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
详细描述
This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.
Steady state levels of minocycline in plasma and skin will be determined.
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
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy male and female subjects 14 to 40 years of age
- •Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)
- •Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation
- •Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation
排除标准
- •Mild, non-inflammatory or nodular acne vulgaris
- •Have current or previous skin cancer
- •Have a history of skin disease or presence of skin condition the PI believes would interfere with the study
- •Females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding
- •Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
- •Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies
研究组 & 干预措施
Oral ER Minocycline - Up to 2mg/kg
Oral extended release minocycline - up to 2mg/kg once a day for 30 days.
干预措施: Minocycline (Drug)
结局指标
主要结局
Plasma Minocycline Level
时间窗: Assessed at week 2 and week 4; reported at week 4
次要结局
- Skin/Dermal Levels of Minocycline(Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules)