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

Phase 2

Completed

• Conditions: Hyperhidrosis
• Interventions: Biological: Placebo comparator; Biological: Botulinum toxin type A

• Registration Number: NCT02565732
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-03
• Disposition First Submitted: 2016-08-02
• Disposition First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Disposition First Posted: 2016-08-04
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose C	Placebo comparator	Placebo comparator
Dose A	Botulinum toxin type A	Botulinum toxin type A
Dose B	Botulinum toxin type A	Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
Gravimetry	Week 4	The amount of sweat measured gravimetrically
Hyperhidrosis Disease Severity Scale (HDSS)	Week 4	Improvement at follow-up in the experimental groups compared to the placebo group

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI)	Week 4