An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects With Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Change in HPA Axis Response to Cosyntropin
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 subjects with acne vulgaris ages 12 years or older.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has moderate to severe facial acne vulgaris as determined by the Investigator's Global Assessment (IGA) and obvious acne on the chest and/or back at study start.
- •Subject has facial acne vulgaris (including the nose) with a minimum number of inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum number of non-inflammatory lesions (open and closed comedones) at study start.
- •Females must be post-menopausal, surgically sterile or using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
- •Subject must be in general good health in the opinion of the investigator, with normal renal function, based on screening physical examination, medical history, and clinical laboratory values.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject is 12-20 years of age and has a Body Mass Index (BMI) for age percentile > 85%.
- •Subject is > 20 years of age and has a BMI > 32.0 kg/m
- •Subject has used tobacco, smoking cessation products, or products containing nicotine within three months prior to study start.
- •Except for the use of contraceptives, subject has used any prescription drug or herbal product within 14 days prior to dosing, any non-prescription drug or vitamin or mineral supplements within 7 days prior to study start; any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of study start.
- •Subject has used topical anti-acne medications containing retinoids such as tazarotene, adapalene or tretinoin, within four weeks of study start.
- •Subject has used the following systemic anti-acne medications: antibiotics within two weeks of study start, spironolactone within four weeks of study start, or retinoid therapy within three months of study start.
- •Subject 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.
- •Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
- •Subject has used light treatments, microdermabrasion or chemical peels to the face, chest and back within eight weeks of study start.
- •Subject cannot avoid any type of strenuous exercise (swimming, running, team sports, etc.,) or the use of hot tubs/saunas from study start to the end of the study.
- •Subject has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has used topical corticosteroids (including inhaled and intranasal corticosteroids) within two weeks of study start.
- •Subject has used systemic corticosteroids (including intramuscular and intralesional injections) within four weeks of study start.
- •Subject has an irregular sleep schedule or works night shifts.
- •Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to study start.
- •Subject tests positive at Screening for human immunodeficiency virus (HIV) or is known to be seropositive for HIV.
- •Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
- •Subject had major surgery within 30 days prior to study start or plans to have surgery during the study.
- •Subject has participated in a previous CB-03-01 study.
研究组 & 干预措施
Cortexolone 17α-Propionate
Topical cream, 1.0% concentration, applied every twelve hours
干预措施: cortexolone 17α-propionate (Drug)
结局指标
主要结局
Change in HPA Axis Response to Cosyntropin
时间窗: Baseline and Day 14
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
PK Profiles (Cmax) of Cortexolone 17α-propionate
时间窗: Baseline and Day 14
Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).
PK Profiles (Cavg) of Cortexolone 17α-propionate
时间窗: Baseline and Day 14
Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).
PK Profiles (AUC) of Cortexolone 17α-propionate
时间窗: Baseline and Day 14
Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application \[0-12 hours\]) and at Day 14 (i.e., Day 14, after last application \[0-12 hours\]).
次要结局
未报告次要终点