Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

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).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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