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

Revance Therapeutics, Inc.0 sites67 target enrollmentSeptember 2015

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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