Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis (NCT02565732) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
United States67 participantsStarted 2015-09
Plain-language summary
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.