A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
研究概览
简要总结
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
详细描述
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
- •At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
- •Age 9-16 years, 11 months inclusive
- •Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
排除标准
- •Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
- •Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
- •Subjects who reside in a dwelling that relies on well water for a primary drinking source
- •Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
- •Transgender subjects receiving hormone supplement (male to female or female to male)
- •Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
- •Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
- •Females who are pregnant, planning a pregnancy or breastfeeding
- •Subjects previously treated with NVN1000 Gel / SB204
研究组 & 干预措施
SB204 4%
Topically Once Daily (AM)
干预措施: SB204 4% (Drug)
结局指标
主要结局
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
时间窗: Day 21
Maximum plasma concentration of plasma hMAP3 on Day 21
AUC - area under the plasma concentration time curve for hMAP3
时间窗: Day 21
AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21
次要结局
- Pharmacokinetics as measured by maximum concentration of nitrate(Day 21)
- Tolerability (Scores on tolerability assessment)(Day 21/End of treatment)
- Safety profile (Reported adverse events)(Day 21/End of Treatment)
- Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3(Day 21)