A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 20% Hair regrowth
研究概览
简要总结
Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth.
The investigators hypothesize that Vytorin medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory process may help in permitting hair regrowth in those subjects.
详细描述
Primary objective:
To evaluate the efficacy of oral simvastatin + ezetimibe (Vytorin) in treating alopecia areata in subjects 18 years and older.
Secondary objective:
To investigate the presence of heat shock proteins in alopecia areata subjects, before and after treatment with oral simvastatin.
Subjects will be asked to take vytorin 10/40 for a period of 24 or 52 weeks and monitored for progression of hair regrowth. They will have Lipids, creatinine kinase (CK), liver function tests (LFTs), obtained on baseline visit prior to starting the medication and at visit 2, week 8. LFTs will be continuously monitored at visit 4, 7, week 24 and week 40.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80% hair loss.
- •Clinical diagnosis of alopecia areata
- •18-years or older
排除标准
- •You are less than 18 years old
- •You are pregnant or planning to be pregnant during the next 12 months.
- •You are nursing a child.
- •You have kidney, liver or muscle disease.
- •You have an allergy to Lidocaine, the study drug or its components.
- •You are presently participating in another clinical trial
- •You are currently using, or have used within the past 3 months, the following:
- •Systemic corticosteroids. (prednisone, methylprednisolone, hydrocortisone etc.)
- •Immunosuppressant agents.(cyclosporine, efalizumab etc.)
- •Any medication that may have interaction with Vytorin (check with the study doctor for other medications you are taking).
- •You are currently using, or have used within the past 2 weeks, any topical medication for the treatment of alopecia areata
- •You have an ongoing hypothyroid problem that is not being treated. If this problem is being treated then you can participate.
研究组 & 干预措施
Vytorin
Subjects will receive Vytorin for 24 weeks. At 24 weeks if regrowth greater or equal than 20%, subjects will be randomized 1/1 to either stop or continue vytorin. Subjects will be follow for additional 24 weeks.
Subjects that at 24 weeks don't meet the 20% regrowth will be dropped out of the study.
干预措施: vytorin (Drug)
结局指标
主要结局
20% Hair regrowth
时间窗: 6 months
would like at least 20% regrowth within 6 months time.
次要结局
- maintenance of hair(6 months)
研究者
Dr. Lawrence Schachner
Chairman of department of Dermatology & Cutaneous Surgery
University of Miami