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

Primary Purpose

Hyperhidrosis, Residual Limbs

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
OnabotulinumtoxinA
Topical Aluminium Chloride (cosmetic product)
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Les Capucins
  • Hôpital Clermont-Tonnerre
  • CMPR La Tour de Gassies
  • Hopital Percy
  • Hopital Laveran
  • Pôle Saint Helier
  • Centre La Tourmaline
  • Institut Universitaire de Réadaptation Clémenceau
  • Institut Robert Merle d'Aubigné, IRMA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OnabotulinumtoxinA

Topical Aluminium Chloride

Arm Description

OnabotulinumtoxinA in intradermal Injections on residual lower limb

Topical Aluminium Chloride (cosmetic product) on the lower limb

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
Amount of time spent wearing the prothesis
Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
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
Quality of life(DLQI)
DLQI quality of life questionnaire : efficacy if increase
Quality of life (physical domain of SF36)
SF36 "limitations due to physical state" specific domain : efficacy if increase
Quality of life (subjective improvement felt)
Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase

Full Information

First Posted
October 19, 2016
Last Updated
April 26, 2021
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT03433859
Brief Title
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Acronym
SALUTOX
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 10, 2020 (Actual)
Study Completion Date
March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Residual Limbs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OnabotulinumtoxinA
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA in intradermal Injections on residual lower limb
Arm Title
Topical Aluminium Chloride
Arm Type
Active Comparator
Arm Description
Topical Aluminium Chloride (cosmetic product) on the lower limb
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA
Other Intervention Name(s)
Botox
Intervention Description
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
Intervention Type
Other
Intervention Name(s)
Topical Aluminium Chloride (cosmetic product)
Intervention Description
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
Primary Outcome Measure Information:
Title
Hyperhidrosis Disease Severity Score (HDSS) evolution
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mismatch of prothesis associated with sweat measured by a visual analogue scale
Description
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure
Time Frame
3 years
Title
Problems with walking due to sweat measured by a visual analogue scale
Description
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure
Time Frame
3 years
Title
Sweat quantity measured by a visual analogue scale
Description
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure
Time Frame
3 years
Title
Quality of life measured by a visual analogue scale
Description
Visual analogue scale (VAS) using 100mm scale. VAS range from 0 to 100mm. Efficacy is considered if > 50% increase between initial and final measure
Time Frame
3 years
Title
Amount of time spent wearing the prothesis
Description
Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
Time Frame
3 years
Title
Prothesis removed to dry the residual limb
Description
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
Time Frame
3 years
Title
Quality of life(DLQI)
Description
DLQI quality of life questionnaire : efficacy if increase
Time Frame
3 years
Title
Quality of life (physical domain of SF36)
Description
SF36 "limitations due to physical state" specific domain : efficacy if increase
Time Frame
3 years
Title
Quality of life (subjective improvement felt)
Description
Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène BISSERIEX, MD
Organizational Affiliation
Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Les Capucins
City
Angers
ZIP/Postal Code
49103
Country
France
Facility Name
Hôpital Clermont-Tonnerre
City
Brest
ZIP/Postal Code
29240
Country
France
Facility Name
CMPR La Tour de Gassies
City
Bruges
ZIP/Postal Code
33523
Country
France
Facility Name
Hopital Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hopital Laveran
City
Marseille
ZIP/Postal Code
13384
Country
France
Facility Name
Pôle Saint Helier
City
Rennes
ZIP/Postal Code
35043
Country
France
Facility Name
Centre La Tourmaline
City
Saint Herblain
ZIP/Postal Code
44818
Country
France
Facility Name
Institut Universitaire de Réadaptation Clémenceau
City
Strasbourg
ZIP/Postal Code
67082
Country
France
Facility Name
Institut Robert Merle d'Aubigné, IRMA
City
Valenton
ZIP/Postal Code
94460
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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