Hyperhidrosis Clinical Trial
— SALUTOXOfficial title:
Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
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 |
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Direction Centrale du Service de Santé des Armées |
France,
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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