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

NCT03433859 | Completed Phase 3 DMC

• 2 other identifiers: 2013RC092014-002068-34
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Hyperhidrosis; Residual Limbs

Outcome Measures

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

  24 weeks

Secondary Outcomes (9)

• Mismatch of prothesis associated with sweat measured by a visual analogue scale

  3 years

• Problems with walking due to sweat measured by a visual analogue scale

  3 years

• Sweat quantity measured by a visual analogue scale

  3 years

• Quality of life measured by a visual analogue scale

  3 years

• Amount of time spent wearing the prothesis

  3 years

Study Arms (2)

OnabotulinumtoxinA

EXPERIMENTAL

OnabotulinumtoxinA in intradermal Injections on residual lower limb

Drug: OnabotulinumtoxinA

Topical Aluminium Chloride

ACTIVE COMPARATOR

Topical Aluminium Chloride (cosmetic product) on the lower limb

Other: Topical Aluminium Chloride (cosmetic product)

Interventions

OnabotulinumtoxinA DRUG

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

Also known as: Botox

OnabotulinumtoxinA

Topical Aluminium Chloride (cosmetic product) OTHER

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

Topical Aluminium Chloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 75 years old
• Written informed consent

You may not qualify if:

• Social assurance
• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (9)

Les Capucins

Angers, 49103, France

Location

Hôpital Clermont-Tonnerre

Brest, 29240, France

Location

CMPR La Tour de Gassies

Bruges, 33523, France

Location

Hopital Percy

Clamart, 92141, France

Location

Hopital Laveran

Marseille, 13384, France

Location

Pôle Saint Helier

Rennes, 35043, France

Location

Centre La Tourmaline

Saint-Herblain, 44818, France

Location

Institut Universitaire de Réadaptation Clémenceau

Strasbourg, 67082, France

Location

Institut Robert Merle d'Aubigné, IRMA

Valenton, 94460, France

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A; Aluminum Chloride; Cosmetics

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Aluminum Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Hélène BISSERIEX, MD

  Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: February 15, 2018
• Study Start: March 1, 2016
• Primary Completion: September 10, 2020
• Study Completion: March 3, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)