A Phase 3 interventional study of OnabotulinumtoxinA and Topical Aluminium Chloride (cosmetic product) in Hyperhidrosis and Residual Limbs, sponsored by Direction Centrale du Service de Santé des Armées. Completed at 9 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Direction Centrale du Service de Santé des Armées · Phase 3, Interventional, and Treatment
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).
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
OnabotulinumtoxinA in intradermal Injections on residual lower limb
Drug: OnabotulinumtoxinA
Topical Aluminium Chloride (cosmetic product) on the lower limb
Other: Topical Aluminium Chloride (cosmetic product)
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
Also known as: Botox
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
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
Time frame: 24 weeks
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
Time frame: 3 years
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
Time frame: 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
Time frame: 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
Time frame: 3 years
Amount of time spent wearing the prothesis
Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
Time frame: 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
Time frame: 3 years
Quality of life(DLQI)
DLQI quality of life questionnaire : efficacy if increase
Time frame: 3 years
Quality of life (physical domain of SF36)
SF36 "limitations due to physical state" specific domain : efficacy if increase
Time frame: 3 years
Quality of life (subjective improvement felt)
Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if\>50% increase
Time frame: 3 years
Plan to share: No
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Direction Centrale du Service de Santé des Armées