NCT04091646已完成2 期
A Phase 2b, 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
- 2 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 24
- 主要终点
- Achievement of Investigator Global Assessment (IGA) Success at Week 8
研究概览
简要总结
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in 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
- 18 Years 至 —（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.
- •Males and females ages 18 years and older (inclusive) at the time of consent.
- •Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- •Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas.
- •An Investigator Global Assessment (IGA) of 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, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
- •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 according to Excluded Medications and Treatments.
- •Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- •Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
- •Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- •Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
- •Previous treatment with ARQ-151 and ARQ-
- •Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
- •Known allergies to excipients in ARQ-154 foam.
- •Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
- •Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- •Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- •Subjects unable to apply product to the scalp due to physical limitations.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
- •Subjects who are unable to communicate, read or understand the local language, or 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 site, clinical study staff, or sponsor, or family members of enrolled subjects.
- •Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
研究组 & 干预措施
Roflumilast Foam 0.3%
Active Comparator
Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks.
干预措施: Roflumilast Foam 0.3% (Drug)
Vehicle Foam
Placebo Comparator
Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.
干预措施: Vehicle foam (Drug)
结局指标
主要结局
Achievement of Investigator Global Assessment (IGA) Success at Week 8
时间窗: Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
次要结局
- Change From Baseline in Overall Assessment of Scaling Score(Weeks 2, 4, and 8)
- Achievement of Overall Assessment of Scaling Success(Weeks 2, 4, and 8)
- Achievement of IGA Success at Weeks 2 and 4(Weeks 2 and 4)
- Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score(Weeks 2, 4, and 8)
- Change From Baseline in Overall Assessment of Erythema Score(Weeks 2, 4, and 8)
- Achievement of Overall Assessment of Erythema Success(Weeks 2, 4, and 8)
- Achievement of WI-NRS Success(Weeks 2, 4, and 8)
研究者
研究点 (24)
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