Status:
COMPLETED
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Hyperhidrosis
Residual Limbs
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03433859
Start Date
March 1 2016
End Date
March 3 2021
Last Update
April 28 2021
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Les Capucins
Angers, France, 49103
2
Hôpital Clermont-Tonnerre
Brest, France, 29240
3
CMPR La Tour de Gassies
Bruges, France, 33523
4
Hopital Percy
Clamart, France, 92141