Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis

This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.

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