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

Hyperhidrosis Clinical Trial

— SALUTOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433859
• Other study ID #: 2013RC09
• Secondary ID: 2014-002068-34
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hyperhidrosis
• Residual Limbs

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