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CompletedNCT03433859SALUTOXUpdated Apr 28, 2021

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

A Phase 3 interventional study of OnabotulinumtoxinA and Topical Aluminium Chloride (cosmetic product) in Hyperhidrosis and Residual Limbs, sponsored by Direction Centrale du Service de Santé des Armées. Completed at 9 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Direction Centrale du Service de Santé des Armées · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Hyperhidrosis
  • Residual Limbs

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    OnabotulinumtoxinA

    OnabotulinumtoxinA in intradermal Injections on residual lower limb

    Drug: OnabotulinumtoxinA

  • Active comparator
    Topical Aluminium Chloride

    Topical Aluminium Chloride (cosmetic product) on the lower limb

    Other: Topical Aluminium Chloride (cosmetic product)

Interventions

  • DrugOnabotulinumtoxinA

    OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose

    Also known as: Botox

  • OtherTopical Aluminium Chloride (cosmetic product)

    Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 weeks

Secondary outcomes

  1. 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

    Time frame: 3 years

  2. 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

    Time frame: 3 years

  3. 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

    Time frame: 3 years

  4. 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

    Time frame: 3 years

  5. Amount of time spent wearing the prothesis

    Amount of time spent wearing the prosthesis (hours per day): efficacy if increase

    Time frame: 3 years

  6. 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

    Time frame: 3 years

  7. Quality of life(DLQI)

    DLQI quality of life questionnaire : efficacy if increase

    Time frame: 3 years

  8. Quality of life (physical domain of SF36)

    SF36 "limitations due to physical state" specific domain : efficacy if increase

    Time frame: 3 years

  9. Quality of life (subjective improvement felt)

    Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if\>50% increase

    Time frame: 3 years

06

Study locations

9 sites
  • Les Capucins
    Angers, 49103, France
  • Hôpital Clermont-Tonnerre
    Brest, 29240, France
  • CMPR La Tour de Gassies
    Bruges, 33523, France
  • Hopital Percy
    Clamart, 92141, France
  • Hopital Laveran
    Marseille, 13384, France
  • Pôle Saint Helier
    Rennes, 35043, France
  • Centre La Tourmaline
    Saint Herblain, 44818, France
  • Institut Universitaire de Réadaptation Clémenceau
    Strasbourg, 67082, France
  • Institut Robert Merle d'Aubigné, IRMA
    Valenton, 94460, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03433859
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Mar 2016
Primary completion
Sep 10, 2020
Completion
Mar 3, 2021
Last update
Apr 28, 2021

Study contacts

Hélène BISSERIEX, MD
principal investigator · Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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