The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
研究概览
简要总结
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.
Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.
The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.
There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.
Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.
The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •All patients must be over 18 years old
- •All patients are diagnosed with alopecia totalis or alopecia universalis
- •The alopecia condition was not responded to any treatments
排除标准
- •Having an active inflammation on scalp area
- •Allergic to botulinum toxin A of human albumin
- •Has been diagnosed with neuromuscular disorders
- •Taking any medication that may interfere with botulinum toxin A action
- •Receiving any treatment for alopecia condition within 4 weeks
- •Pregnant , breastfeeding, plan to pregnant patients
研究组 & 干预措施
Botulinum toxin A
The area of alopecia is splited into experimental and control sides by blocked randomization. Experimental sides injected with botulinum toxin A at 2 units per 0.1 ml of dilution with normal saline entire all area.
干预措施: Botulinum toxin A (Drug)
Placebo
Using normal saline
干预措施: Normal saline injection (Drug)
结局指标
主要结局
To evaluate the percentage of terminal hair regrowth in recalcitrant alopecia totalis and alopecia universalis after intralesional botulinum toxin A injection
时间窗: 4 months
次要结局
- To evaluate any possible side effects of intralesional botulinum toxin A injection for alopecia totalis and alopecia universalis(4 months)
研究者
Rattapon Thuangtong
Assistant professor
Siriraj Hospital