A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled, Single Site, Exploratory Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
研究概览
简要总结
This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.
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
- Double (Participant, Investigator)
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
Delgocitinib - Delgocitinib
Participants were blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
干预措施: Delgocitinib cream (Drug)
Placebo - Delgocitinib
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
干预措施: Delgocitinib cream (Drug)
Placebo - Delgocitinib
Participants were blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks.
干预措施: Delgocitinib cream vehicle (Drug)
结局指标
主要结局
Change in Expression of Chemokine (C-X-C Motif) Ligand 9 (CXCL9), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), and Interferon (IFN)-γ From Baseline to Week 12.
时间窗: Baseline and Week 12
CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.
次要结局
- Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.(Between baseline and Week 12)