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

Study Overview
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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.

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).

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

Conditions
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Hyperhidrosis, Residual Limbs

Intervention / Treatment
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* Drug: OnabotulinumtoxinA
* Other: Topical Aluminium Chloride (cosmetic product)


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OnabotulinumtoxinA<br>OnabotulinumtoxinA in intradermal Injections on residual lower limb | Drug: OnabotulinumtoxinA<br>* OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose<br>* Other names: Botox;|
| Active Comparator: Topical Aluminium Chloride<br>Topical Aluminium Chloride (cosmetic product) on the lower limb | Other: Topical Aluminium Chloride (cosmetic product)<br>* Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperhidrosis Disease Severity Score (HDSS) evolution | 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 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mismatch of prothesis associated with sweat measured by a visual analogue scale | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure | 3 years | 
| Problems with walking due to sweat measured by a visual analogue scale | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure | 3 years | 
| Sweat quantity measured by a visual analogue scale | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure | 3 years | 
| Quality of life measured by a visual analogue scale | Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure | 3 years | 
| Amount of time spent wearing the prothesis | Amount of time spent wearing the prosthesis (hours per day): efficacy if increase | 3 years | 
| Prothesis removed to dry the residual limb | Number of times the prosthesis had to be removed to dry the residual limb and sleeve per day: efficacy if no need to remove it or only once a day | 3 years | 
| Quality of life(DLQI) | DLQI quality of life questionnaire : efficacy if increase | 3 years | 
| Quality of life (physical domain of SF36) | SF36 limitations due to physical state specific domain : efficacy if increase | 3 years | 
| Quality of life (subjective improvement felt) | Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase | 3 years |