The Quadrant vs the Six Injection Technique in Primary Focal Hyperhidrosis Using Botulinum Toxin: a Cross-over Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- objective iodine startch
研究概览
简要总结
The purpose of this study is to describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.
详细描述
The abobotulinumtoxinA (ABO) will be used in all patients. The ABO will be prepared by adding 4 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection patient pictures will be taken showing the technique used for each armpit.
Injection technique:
- Technique 1 The Quadrant technique: 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum
- Technique 2 the six injection technique: will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units
Follow up will be done at 15 days for post injection pictures with iodine starch test A total of 15 male patients will be recruited. And the injection for each armpit in a given patient is randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
the objective assessment with iodine starch test
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Consecutive 15 male patients presenting to our clinic for primary localized hyperhidrosis will be included in this study
排除标准
- •Patient that has received a botulinum injection in the past year
- •Patient that had a liposuction in the armpit or laser for the hair
- •Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome) Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics) Patients with sensitivity to botulinum toxin or human albumin
研究组 & 干预措施
Technique 1 The Quadrant technique
Intervention: 25 Botulinum Toxin injections. 5 vertical lines and 5 horizontal lines will be draw on the hair bearing area of the armpit amounting to 25 injection points being more concentrated on the center. Each injection consists of 5Units of abobotulinum
干预措施: botulinum toxin A (Drug)
Technique 2 the six injection technique
Intervention: 6 Botulinum Toxin injections. will consist on 6 injections in the hair bearing area equally spaced with each consisting of 8units
干预措施: botulinum toxin A (Drug)
结局指标
主要结局
objective iodine startch
时间窗: 3weeks
Objective assessment will be done using the iodine starch after a 5 min jumping jack on the post injection visit.
次要结局
- subjective: patient satisfaction(3 weeks)
- subjective: pain on injection(day 0)
研究者
samer jabbour
M.D
St Joseph University, Beirut, Lebanon