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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT02565732
Eligibility Criteria:
Inclusion Criteria:
* Primary axillary hyperhidrosis
* Female or male, 18 years of age or older in good general health
* Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
* Axillary sweat production of at least 50 mg/5 min measured gravimetrically
Exclusion Criteria:
* Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
* Muscle weakness or paralysis, particularly in the upper extremities
* Active skin disease or irritation or disrupted barrier at the treatment area
* Undergone any procedures which may affect the axillary areas
* Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
* Any prior axillary use of an anti-hyperhidrosis medical device
* If menopausal had symptoms of menopause such as sweating or flushing within the last year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02565732
Study Brief:
Protocol Section:
NCT02565732