Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
研究概览
简要总结
The purpose of this study is to examine prospectively the safety and efficacy of Botulinum Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.
详细描述
Hypothesis Intralesional injections of Botulinum Toxin A can be used as a treatment for AA. Potential points of action of this treatment include changes in neurotransmitters, which either directly or via neuroimmunologic mechanisms influence cytocines that are responsible for the hair growth arrest in alopecia areata.
Justification Botulinum Toxin A is an antagonist of Acetylcholine esterase and is used to treat facial wrinkles and hyperhidrosis. One ampoule contains Clostridium Botulinum Toxin Typ A (900kD) 100 E, other components are human albumin and sodium choride. The investigator has learnt about the potential effect of this treatment in AA from personal communication.
Objectives Over a period of 6 month, to assess the therapeutic efficacy and safety of a regimen of two interlesional injections of Botulinum Toxin A at 0 and 3 months, in patients with alopecia areata of the scalp, compared to placebo.
Research Method A total of 20 eligible patients will be enrolled in the study. All patients will receive treatment into one half of their target area and placebo treatment into the other half of their target area.
Measurement of the severity of scalp alopecia areata will be based on the extent terminal scalp hair loss. The Severity of Alopecia Tool (SALT) will be used, which determines the percent of scalp involvement with disease as calculated according to specifications detailed in the Alopecia Areata Investigational Guidelines by Olsen et al..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with long standing alopecia areata, patches must be at least 4 cm in diameter
排除标准
- •Intake of drugs that interfere with Botulinum toxin A such as gentamicin, tobramycin, clindamycin and lincomycin; medications used to treat heart rhythm problems, such as quinidine; and medications used to treat other conditions, such as myasthenia gravis, ALS or Alzheimer's disease.
- •Neuromuscular disorders such as Myasthenia gravis and Lambert-Eaton-Syndrome.
- •Treatment with another investigational drug within 4 weeks prior to anticipated first treatment.
- •Females who are pregnant, planning to become pregnant during the study period, or breastfeeding.
结局指标
主要结局
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
次要结局
- Hair regrowth will be assessed after 3 months and 6 months