Hyperhidrosis
Conditions
Brief summary
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
Interventions
BIOLOGICALBotulinum toxin type A
Botulinum toxin type A, Dose A, Topical
BIOLOGICALPlacebo comparator
Placebo, Dose C, Topical
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperhidrosis Disease Severity Scale (HDSS) | Week 4 | Improvement at follow-up in the experimental groups compared to the placebo group |
| Gravimetry | Week 4 | The amount of sweat measured gravimetrically |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI) | Week 4 |
Countries
United States
Outcome results
None listed