A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 22
- 主要终点
- Subject incidence of adverse events
研究概览
简要总结
This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).
详细描述
This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).
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
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of a parent(s) or legal guardian(s), as required by local laws.
- •Males and females, ages 3 months to <2 years old at Day
- •Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.
- •Has AD involvement of ≥3% BSA at Day
- •In good health as judged by the Investigator
- •Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
排除标准
- •Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- •Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
- •Subjects previously treated with ARQ-151
- •Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.
- •Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- •Subjects who are family members of the clinical study staff or sponsor.
研究组 & 干预措施
ARQ-151 roflumilast cream 0.05% (open label)
This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.
干预措施: ARQ-151 cream 0.05% (Drug)
结局指标
主要结局
Subject incidence of adverse events
时间窗: 4 weeks
Number of participants with adverse events during treatment will be assessed
Subject incidence of serious adverse events
时间窗: 4 weeks
Number of participants with serious adverse events during treatment will be assessed
Incidence of application site reactions
时间窗: 4 weeks
Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed
次要结局
未报告次要终点