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

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

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

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis; Residual Limbs
• Intervention / Treatment: Drug: OnabotulinumtoxinA; Other: Topical Aluminium Chloride (cosmetic product)

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).

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49103
    • Les Capucins
  • Brest, France, 29240
    • Hôpital Clermont-Tonnerre
  • Bruges, France, 33523
    • CMPR La Tour de Gassies
  • Clamart, France, 92141
    • Hôpital Percy
  • Marseille, France, 13384
    • Hopital Laveran
  • Rennes, France, 35043
    • Pole Saint Helier
  • Saint Herblain, France, 44818
    • Centre La Tourmaline
  • Strasbourg, France, 67082
    • Institut Universitaire de Réadaptation Clemenceau
  • Valenton, France, 94460
    • Institut Robert Merle d'Aubigné, IRMA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Investigators: Principal Investigator: Hélène BISSERIEX, MD, Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2013RC09; 2014-002068-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No