NCT03433859

Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

Prospective Multicentric Open Randomised Controlled Trial Comparing Topical Aluminium Chloride to OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 1 phone call (week 18).

Conditions

• Hyperhidrosis
• Residual Limbs

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
OTHER	Topical Aluminium Chloride (cosmetic product)	Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-09-10
• Completion: 2021-03-03
• First posted: 2018-02-15
• Last updated: 2021-04-28

Locations

9 sites across 1 country: France