Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT03433859
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03433859
Study Brief:
Protocol Section:
NCT03433859