An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Change in HPA Axis Response as Measured by CST
研究概览
简要总结
This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns 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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
- •Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
- •Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
- •Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
- •Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.
排除标准
- •Patient is pregnant, lactating, or is planning to become pregnant during the study.
- •Patient has a Body Mass Index (BMI) for age percentile > 95%.
- •Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
- •Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
- •Patient is currently enrolled in an investigational drug or device study.
- •Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
- •Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
- •Patient has participated in a previous CB-03-01 study.
研究组 & 干预措施
CB-03-01 cream, 1%
Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days
干预措施: cortexolone 17α-propionate (Drug)
结局指标
主要结局
Change in HPA Axis Response as Measured by CST
时间窗: Pre- and Post-CST on Day 14
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
次要结局
- Evaluate Trough Plasma Concentrations(14 Days)