Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment Response to Ruxolitinib 1.5% Cream
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4
研究概览
简要总结
This study is an open-label prospective interventional trial that will assess the efficacy of ruxolitinib in the treatment of seborrheic dermatitis. It will also attempt to characterize the molecular immune profiles of patients with SD at week 0 and week 4, with comparison to baseline profiles in healthy control subjects.
详细描述
The study will include 25 adult patients with moderate-to-severe-SD as well as 20 age- and gender-matched healthy control subjects for comparison. The SD patients will have baseline clinical score of at least 6 using the SD Severity Score in Appendix 1, or an Investigator Global Assessment (IGA) score of at least 3. Enrolled SD subjects will apply topical ruxolitinib 1.5% cream twice daily for 4 weeks. They will return for visits at weeks 2, 4, and 6 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ruxolitinib Cream
Participants will receive topical ruxolitinib 1.5% cream
干预措施: Ruxolitinib 1.5% Cream (Drug)
结局指标
主要结局
Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4
时间窗: At end of Treatment, Week 4
Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4 IGA Scale from 0-4 Clear 0 No signs of SD Almost Clear 1 Just perceptible erythema and just perceptible scaling Mild 2 Mild erythema and mild scaling Moderate 3 Moderate erythema and moderate scaling Severe 4 Severe erythema and severe scaling
次要结局
- Change in Investigator Global Assessment From Baseline to Week 4(Baseline and Week 4)
- Mean Change in Seborrheic Dermatitis Severity Score(Baseline, Week 4, Week 6)
- Mean Change in Seborrheic Dermatitis Severity Score for Scale(Baseline, Week 4, and Week 6)
- Change in Seborrheic Dermatitis Severity Score for Erythema(Baseline, Week 4, and Week 6)
- Change in Seborrheic Dermatitis Severity Score for Pruritus(Baseline Week 4, and Week 6)
- Frequency of Adverse Events(6 weeks)
- Duration of Adverse Events(6 weeks)
- Severity of Adverse Events(6 weeks)
研究者
Benjamin Ungar
Assistant Professor
Icahn School of Medicine at Mount Sinai