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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433859
Other study ID # 2013RC09
Secondary ID 2014-002068-34
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2016
Est. completion date March 3, 2021

Study information

Verified date April 2021
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 3, 2021
Est. primary completion date September 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
OnabotulinumtoxinA
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
Other:
Topical Aluminium Chloride (cosmetic product)
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb

Locations

Country Name City State
France Les Capucins Angers
France Hôpital Clermont-Tonnerre Brest
France CMPR La Tour de Gassies Bruges
France Hopital Percy Clamart
France Hopital Laveran Marseille
France Pôle Saint Helier Rennes
France Centre La Tourmaline Saint Herblain
France Institut Universitaire de Réadaptation Clémenceau Strasbourg
France Institut Robert Merle d'Aubigné, IRMA Valenton

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Amount of time spent wearing the prothesis Amount of time spent wearing the prosthesis (hours per day): efficacy if increase 3 years
Secondary 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
Secondary Quality of life(DLQI) DLQI quality of life questionnaire : efficacy if increase 3 years
Secondary Quality of life (physical domain of SF36) SF36 "limitations due to physical state" specific domain : efficacy if increase 3 years
Secondary Quality of life (subjective improvement felt) Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase 3 years
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