Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Hyperhidrosis Disease Severity Score (HDSS) evolution
研究概览
简要总结
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
详细描述
After randomization patients will receive either OnabotulinumtoxinA once or topical aluminium chloride for 6 months. All patients will be evaluated during 3 study visits (week 4, week 12, week 24) and 1 phone call (week 18).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lower limb amputees suffering from residual limb hyperhidrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause
- •HDSS ≥ 2 (Hyperhidrosis Disease Severity Score)
- •Men and women
- •18 to 75 years old
- •Written informed consent
- •No exclusion criteria
- •Social assurance
排除标准
- •Botulinum toxin injection necessity for another disease
- •Evolutive Central neurologic disease or myasthenia.
- •Egg or albumine allergy
- •Botulinum toxin or other excipients hypersensibility
- •Legally protected Adults and people unable to give an informed consent. (article L-1121-8 from Public Health Code), people without freedom and people hospitalized without consent (article L-1121-6 from Public Health Code)
- •Pregnant women or giving breast women (article L-1121-5 from Public Health)
- •Patient refusing participating
- •Previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks
- •Previous hyperhidrosis treatment with botulinum toxin in the last 2 years
- •Other ongoing hyperhidrosis treatment
- •Large residual limb eczematiform lesions: corticoids treatment (for example: Locapred® 1 application per day during 1 week then decrease).
- •Aminoglycoside ongoing treatment
研究组 & 干预措施
OnabotulinumtoxinA
OnabotulinumtoxinA in intradermal Injections on residual lower limb
干预措施: OnabotulinumtoxinA (Drug)
Topical Aluminium Chloride
Topical Aluminium Chloride (cosmetic product) on the lower limb
干预措施: Topical Aluminium Chloride (cosmetic product) (Other)
结局指标
主要结局
Hyperhidrosis Disease Severity Score (HDSS) evolution
时间窗: 24 weeks
HDSS score : min 1 - max. 4 * Efficacy : HDSS evolution from 2 (initial measure) to 1 (final measure), from 3 (initial measure) to 1 or 2 (final measure), from 4 (initial measure) to 1 or 2 (final measure) * Failure : from 2 (initial measure) to 2 (final measure), from 3 or 4 (initial measure) to 2 (final measure) ; or increase of HDSS between initial and final measure
次要结局
- Mismatch of prothesis associated with sweat measured by a visual analogue scale(3 years)
- Problems with walking due to sweat measured by a visual analogue scale(3 years)
- Sweat quantity measured by a visual analogue scale(3 years)
- Quality of life measured by a visual analogue scale(3 years)
- Amount of time spent wearing the prothesis(3 years)
- Prothesis removed to dry the residual limb(3 years)
- Quality of life(DLQI)(3 years)
- Quality of life (physical domain of SF36)(3 years)
- Quality of life (subjective improvement felt)(3 years)