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

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ClinicalTrials.gov Identifier: NCT03433859
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Residual Limbs Drug: OnabotulinumtoxinA Other: Topical Aluminium Chloride (cosmetic product) Phase 3

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  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Study Start Date : March 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: 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




Primary Outcome Measures :
  1. Hyperhidrosis Disease Severity Score (HDSS) evolution [ Time Frame: 24 weeks ]

    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


Secondary Outcome Measures :
  1. Mismatch of prothesis associated with sweat measured by a visual analogue scale [ Time Frame: 3 years ]
    Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure

  2. Problems with walking due to sweat measured by a visual analogue scale [ Time Frame: 3 years ]
    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. Sweat quantity measured by a visual analogue scale [ Time Frame: 3 years ]
    Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure

  4. Quality of life measured by a visual analogue scale [ Time Frame: 3 years ]
    Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure

  5. Amount of time spent wearing the prothesis [ Time Frame: 3 years ]
    Amount of time spent wearing the prosthesis (hours per day): efficacy if increase

  6. Prothesis removed to dry the residual limb [ Time Frame: 3 years ]
    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

  7. Quality of life(DLQI) [ Time Frame: 3 years ]
    DLQI quality of life questionnaire : efficacy if increase

  8. Quality of life (physical domain of SF36) [ Time Frame: 3 years ]
    SF36 "limitations due to physical state" specific domain : efficacy if increase

  9. Quality of life (subjective improvement felt) [ Time Frame: 3 years ]
    Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433859


Contacts
Contact: Hélène BISSERIEX, MD +33(0)298437303 helene.bisseriex@intradef.gouv.fr

Locations
France
Les Capucins Recruiting
Angers, France, 49103
Contact: Patrick BRUNEL, MD    +33(0)241351701    patrick.brunel@les-capucins-angers.fr   
Hôpital Clermont-Tonnerre Recruiting
Brest, France, 29240
Contact: Hélène BISSERIEX, MD    +33(0)298437303    helene.bisseriex@intradef.gouv.fr   
CMPR La Tour de Gassies Recruiting
Bruges, France, 33523
Contact: Rémi KLOTZ, M.D.    +33(0)5 56 16 32 92    rklotz.gassies@ugecamaq.fr   
Hopital Percy Recruiting
Clamart, France, 92141
Contact: Leo BORRINI, MD    +33(0)141466284    leo.borrini@intradef.gouv.fr   
Hopital Laveran Recruiting
Marseille, France, 13384
Contact: Laurent THEFENNE, MD    +33(0)491617132    laurent.thefenne@intradef.gouv.fr   
Pôle Saint Helier Recruiting
Rennes, France, 35043
Contact: Emilie LEBLONG, M.D.    +33(0)2 99 29 50 88      
Centre La Tourmaline Recruiting
Saint Herblain, France, 44818
Contact: Dominique EVENO, MD    +33(0)240385746    deveno@ugecam-brpl.fr   
Institut Universitaire de Réadaptation Clémenceau Recruiting
Strasbourg, France, 67082
Contact: Mathieu BERTHEL, MD    +33(0)388211694    mathieu.berthel@ugecam-alsace.fr   
Institut Robert Merle d'Aubigné, IRMA Recruiting
Valenton, France, 94460
Contact: Souhila CHAIBEDDRA TANI, M.D.    +33(0)1 45 10 80 80      
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
Principal Investigator: Hélène BISSERIEX, MD Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)

Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT03433859     History of Changes
Other Study ID Numbers: 2013RC09
2014-002068-34 ( EudraCT Number )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Aluminum chloride
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Astringents
Dermatologic Agents