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

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperhidrosis

Treatments: Biological: Botulinum toxin type A; Biological: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02565732

RT001-CL045

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 3 patient groups, including a placebo group

Dose A

Experimental group

Description:

Botulinum toxin type A

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dose B

Experimental group

Description:

Botulinum toxin type A

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Dose C

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Biological: Placebo comparator