Trial | NCT03433859  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    54
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).
Study Started
Mar 31
2016
Primary Completion
Sep 10
2020
Study Completion
Mar 03
2021
Last Update
Apr 28
2021

Drug OnabotulinumtoxinA

OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose

  • Other names: Botox

Other Topical Aluminium Chloride (cosmetic product)

Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb

OnabotulinumtoxinA Experimental

OnabotulinumtoxinA in intradermal Injections on residual lower limb

Topical Aluminium Chloride Active Comparator

Topical Aluminium Chloride (cosmetic product) on the lower limb

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
No Results Posted