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

• Status: Completed
• Trial end date: 2021-03-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Direction Centrale du Service de Santé des Armées
• Treatments: abobotulinumtoxinA; Aluminum chloride; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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