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Completed

NCT Number: NCT03433859

Topical Aluminium Chloride vs 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.

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Key information

Conditions

Hyperhidrosis Residual Limbs Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Les Capucins, Angers, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnabotulinumtoxinA

Drug

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

Other names: Botox

Topical Aluminium Chloride (cosmetic product)

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Official study title

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

Acronym: SALUTOX

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Feb 15, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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