HyperhidrosisPhase 3SALUTOXNCT03433859
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
A Phase 3 study testing OnabotulinumtoxinA and Topical Aluminium Chloride (cosmetic product) in people with Hyperhidrosis and Residual Limbs, run by Direction Centrale du Service de Santé des Armées at 9 sites in France.
Trial summary
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperhidrosis, Residual Limbs
- What is being tested?
- OnabotulinumtoxinA and Topical Aluminium Chloride (cosmetic product)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2016to 3 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Les Capucins
Angers, 49103
Hôpital Clermont-Tonnerre
Brest, 29240
CMPR La Tour de Gassies
Bruges, 33523
Hopital Percy
Clamart, 92141
Hopital Laveran
Marseille, 13384
Pôle Saint Helier
Rennes, 35043
Centre La Tourmaline
Saint-Herblain, 44818
Institut Universitaire de Réadaptation Clémenceau
Strasbourg, 67082
Institut Robert Merle d'Aubigné, IRMA
Valenton, 94460
About this study
Official title: Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
Read the detailed 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).
- Conditions
- Hyperhidrosis, Residual Limbs
- Being tested
- OnabotulinumtoxinA, Topical Aluminium Chloride (cosmetic product)
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called Botox
OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
Topical Aluminium Chloride (cosmetic product)Other
Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA | Experimental | OnabotulinumtoxinA in intradermal Injections on residual lower limb Receives: Drug: OnabotulinumtoxinA |
| Topical Aluminium Chloride | Active comparator | Topical Aluminium Chloride (cosmetic product) on the lower limb Receives: Other: Topical Aluminium Chloride (cosmetic product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
Amount of time spent wearing the prothesis
Amount of time spent wearing the prosthesis (hours per day): efficacy if increase
Measured: 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
Measured: 3 years
Quality of life(DLQI)
DLQI quality of life questionnaire : efficacy if increase
Measured: 3 years
Quality of life (physical domain of SF36)
SF36 "limitations due to physical state" specific domain : efficacy if increase
Measured: 3 years
Quality of life (subjective improvement felt)
Subjective Improvement Felt (SIF) (based on a percentage scale) :efficacy if>50% increase
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startMar 2016
- Primary completion10 Sep 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BISSERIEX, MD, Principal investigator, Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433859
- Sponsor's protocol ID
- 2013RC09
- Other IDs
- 2014-002068-34, 2014
- Acronym
- SALUTOX
- Status last verified
- Apr 2021
- First submitted
- 19 Oct 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
- ClinicalTrials.gov ID
- NCT03433859
- Acronym / sponsor ID
- SALUTOX / 2013RC09
- Conditions
- Hyperhidrosis, Residual Limbs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA in intradermal Injections on residual lower limb |
| Topical Aluminium Chloride | Active comparator | Other: Topical Aluminium Chloride (cosmetic product)Topical Aluminium Chloride (cosmetic product) on the lower limb |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: BotoxOnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose | Drug | OnabotulinumtoxinA |
| Topical Aluminium Chloride (cosmetic product)Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb | Other | Topical Aluminium Chloride |
Primary outcome
Hyperhidrosis Disease Severity Score (HDSS) evolution
Time frame: 24 weeks
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
9 secondary outcomes
Mismatch of prothesis associated with sweat measured by a visual analogue scale
Time frame: 3 years
Problems with walking due to sweat measured by a visual analogue scale
Time frame: 3 years
Sweat quantity measured by a visual analogue scale
Time frame: 3 years
Quality of life measured by a visual analogue scale
Time frame: 3 years
Amount of time spent wearing the prothesis
Time frame: 3 years
Prothesis removed to dry the residual limb
Time frame: 3 years
Quality of life(DLQI)
Time frame: 3 years
Quality of life (physical domain of SF36)
Time frame: 3 years
Quality of life (subjective improvement felt)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène BISSERIEX, MD principal investigator
Service de Santé des Armées, Hôpital Clermont-Tonnerre (Brest, France)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OnabotulinumtoxinA and Topical Aluminium Chloride (cosmetic product) in people with Hyperhidrosis and Residual Limbs, run by Direction Centrale du Service de Santé des Armées at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperhidrosis Disease Severity Score (HDSS) evolution (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.