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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperhidrosis

In brief

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

Key facts

Study ID

NCT02565732

Run by

Revance Therapeutics, Inc.

People needed

67

Starts

2015-09-01

Expected to finish

2016-01-01

Last updated by the study team

2016-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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