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

Direction Centrale du Service de Santé des Armées

Status and phase: Completed; Phase 3

Conditions: Residual Limbs; Hyperhidrosis

Treatments: Drug: OnabotulinumtoxinA; Other: Topical Aluminium Chloride (cosmetic product)

Study type: Interventional

Funder types: Other

Identifiers

NCT03433859

2013RC09

2014-002068-34 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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).

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

OnabotulinumtoxinA

Experimental group

Description:

OnabotulinumtoxinA in intradermal Injections on residual lower limb

Treatment:

Drug: OnabotulinumtoxinA

Topical Aluminium Chloride

Active Comparator group

Description:

Topical Aluminium Chloride (cosmetic product) on the lower limb

Treatment:

Other: Topical Aluminium Chloride (cosmetic product)