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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002068-34 | EudraCT Number |
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The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Experimental | OnabotulinumtoxinA in intradermal Injections on residual lower limb |
|
| Topical Aluminium Chloride | Active Comparator | Topical Aluminium Chloride (cosmetic product) on the lower limb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyperhidrosis Disease Severity Score (HDSS) evolution | HDSS score : min 1 - max. 4
| 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Problems with walking due to sweat measured by a visual analogue scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène BISSERIEX, MD | Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Capucins | Angers | 49103 | France | |||
| Hôpital Clermont-Tonnerre |
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| Topical Aluminium Chloride (cosmetic product) | Other | Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb |
|
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 |
| 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 |
| 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 |
| Amount of time spent wearing the prothesis | Amount of time spent wearing the prosthesis (hours per day): efficacy if increase | 3 years |
| 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 |
| Quality of life(DLQI) | DLQI quality of life questionnaire : efficacy if increase | 3 years |
| Quality of life (physical domain of SF36) | SF36 "limitations due to physical state" specific domain : efficacy if increase | 3 years |
| Quality of life (subjective improvement felt) | Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase | 3 years |
| Brest |
| 29240 |
| France |
| CMPR La Tour de Gassies | Bruges | 33523 | France |
| Hopital Percy | Clamart | 92141 | France |
| Hopital Laveran | Marseille | 13384 | France |
| Pôle Saint Helier | Rennes | 35043 | France |
| Centre La Tourmaline | Saint-Herblain | 44818 | France |
| Institut Universitaire de Réadaptation Clémenceau | Strasbourg | 67082 | France |
| Institut Robert Merle d'Aubigné, IRMA | Valenton | 94460 | France |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077410 | Aluminum Chloride |
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D017607 | Aluminum Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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