Efficacy and Safety of Topical Therapy of Metformin 30%; Simvastatin 2%; and Betamethasone Valerate 0.1% in Treatment of Patients With Patchy Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- hair regrowth in alopecia patch
研究概览
简要总结
Alopecia areata (AA) is a chronic immune disease characterized by non-scarring hair loss of the scalp or other hair-bearing areas Patients with AA frequently report high levels of dissatisfaction with commonly used treatment options due to ineffectiveness and adverse effects. Therefore, a substantial unmet need exists for safe and effective treatments for patients with AA. Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. The main mechanism of action for metformin involves enhancing insulin sensitivity, reducing gluconeogenesis, and promoting the absorption of glucose in muscles.
In addition to its hypoglycemic effect, metformin can serve as an anti-inflammatory agent.Statins are hydroxy-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, commonly used for their lipid-lowering properties to lower cholesterol levels and treat cardiovascular disease, but they also possess powerful anti-inflammatory and immunomodulatory effects.
Simvastatin belongs to the statin family. Lately, Simvastatin is utilized in treatment of several dermatological diseases. It showed efficacy in treatment of psoriasis , vitiligo, xanthomas, atopic dermatitis and acne vulgaris.
This study is considered as the first study to assess and compare the efficacy and safety of of topical therapy of metformin 30 %; simvastatin 2 %; and betamethasone valerate 0.1 % in treatment of patients with patchy alopecia areata.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients of both sexes aged ≥ 6 years (children and adults), having clinical and trichscopic finding of alopecia areata (involving < 50% of the total scalp) and did not receive any topical or systemic treatment in the last 3 months for alopecia areata.
排除标准
- •Alopecia totalis and alopecia universalis.
- •Cicatricial alopecia.
- •Other causes of hair loss such as; endocrine or immunological disease.
- •Skin disease in the affected area.
- •Hypersensitivity to any of the treatment products used.
结局指标
主要结局
hair regrowth in alopecia patch
时间窗: baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion
hair regrowth will be evaluated using the severity of alopecia tool (SALT) score. the SALT score ranges from 0 to 100, with lower scores indicating less scalp hair loss ( better outcome).
次要结局
未报告次要终点
研究者
Sherein Gamal Abdellah
assistant lecturer of dermatology
Sohag University
