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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-03-03

Brief Summary

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

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Detailed Description

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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).

Conditions

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Hyperhidrosis Residual Limbs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OnabotulinumtoxinA

OnabotulinumtoxinA in intradermal Injections on residual lower limb

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

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

Topical Aluminium Chloride

Topical Aluminium Chloride (cosmetic product) on the lower limb

Group Type ACTIVE_COMPARATOR

Topical Aluminium Chloride (cosmetic product)

Intervention Type OTHER

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

Interventions

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OnabotulinumtoxinA

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

Intervention Type DRUG

Topical Aluminium Chloride (cosmetic product)

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

Intervention Type OTHER

Other Intervention Names

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Botox

Eligibility Criteria

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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

Exclusion Criteria

* Social assurance

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No