Back to resultsSafety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
Botulinum toxin type A
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dose A
Dose B
Dose C
Arm Description
Botulinum toxin type A
Botulinum toxin type A
Placebo comparator
Outcomes
Primary Outcome Measures
Hyperhidrosis Disease Severity Scale (HDSS)
Improvement at follow-up in the experimental groups compared to the placebo group
Gravimetry
The amount of sweat measured gravimetrically
Secondary Outcome Measures
Dermatology Life Quality Index (DLQI)
Full Information
NCT ID
NCT02565732
First Posted
September 29, 2015
Last Updated
August 2, 2016
Sponsor
Revance Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02565732
Brief Title
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revance Therapeutics, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose A
Arm Type
Experimental
Arm Description
Botulinum toxin type A
Arm Title
Dose B
Arm Type
Experimental
Arm Description
Botulinum toxin type A
Arm Title
Dose C
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Botulinum toxin type A, Dose A, Topical
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Botulinum toxin type A, Dose B, Topical
Intervention Type
Biological
Intervention Name(s)
Placebo comparator
Intervention Description
Placebo, Dose C, Topical
Primary Outcome Measure Information:
Title
Hyperhidrosis Disease Severity Scale (HDSS)
Description
Improvement at follow-up in the experimental groups compared to the placebo group
Time Frame
Week 4
Title
Gravimetry
Description
The amount of sweat measured gravimetrically
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI)
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
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