Clinical trial NCT03433859: Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Official title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Residual Limbs
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Hyperhidrosis Disease Severity Score (HDSS) evolution
timeFrame: 24 weeks
Secondary outcomes:
measure: Mismatch of prothesis associated with sweat measured by a visual analogue scale
timeFrame: 3 years
measure: Problems with walking due to sweat measured by a visual analogue scale
timeFrame: 3 years
measure: Sweat quantity measured by a visual analogue scale
timeFrame: 3 years
measure: Quality of life measured by a visual analogue scale
timeFrame: 3 years
measure: Amount of time spent wearing the prothesis
timeFrame: 3 years
measure: Prothesis removed to dry the residual limb
timeFrame: 3 years
measure: Quality of life(DLQI)
timeFrame: 3 years
measure: Quality of life (physical domain of SF36)
timeFrame: 3 years
measure: Quality of life (subjective improvement felt)
timeFrame: 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Les Capucins
city: Brest
country: France
facility: Hôpital Clermont-Tonnerre
city: Bruges
country: France
facility: CMPR La Tour de Gassies
city: Clamart
country: France
facility: Hopital Percy
city: Marseille
country: France
facility: Hopital Laveran
city: Rennes
country: France
facility: Pôle Saint Helier
city: Saint Herblain
country: France
facility: Centre La Tourmaline
city: Strasbourg
country: France
facility: Institut Universitaire de Réadaptation Clémenceau
city: Valenton
country: France
facility: Institut Robert Merle d'Aubigné, IRMA
Study officials:
affiliation: Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)
name: Hélène BISSERIEX, MD
role: PRINCIPAL_INVESTIGATOR
References: