NCT04973228已完成3 期
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 457
- 试验地点
- 53
- 主要终点
- Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
研究概览
简要总结
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- •Males and females ages 9 years and older at the time of consent.
- •Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- •Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- •An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
- •Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
- •Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
- •Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- •Subjects in good health as judged by the Investigator.
- •Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
排除标准
- •Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
- •Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- •Previous treatment with ARQ-154 or ARQ-
- •Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- •Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
- •Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
研究组 & 干预措施
Roflumilast Foam 0.3%
Experimental
Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.
干预措施: Roflumilast Foam (Drug)
Vehicle Foam
Placebo Comparator
Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.
干预措施: Vehicle Foam (Drug)
结局指标
主要结局
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
时间窗: Week 8
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
次要结局
- Achievement of Success on the IGA at Week 2(Week 2)
- Achievement of Success in the WI-NRS at Week 2(Week 2)
- Achievement of Success on the IGA at Week 4(Week 4)
- Achievement of Overall Assessment of Scaling Score of 0 at Week 8(Week 8)
- Achievement of Overall Assessment of Erythema Score of 0 at Week 8(Week 8)
- Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8(Week 8)
- Achievement of Success in the WI-NRS at Week 4(Week 4)
研究者
研究点 (53)
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