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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02565732
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Biological: Botulinum toxin type A Biological: Placebo comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Dose A
Botulinum toxin type A
Biological: Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical

Experimental: Dose B
Botulinum toxin type A
Biological: Botulinum toxin type A
Botulinum toxin type A, Dose B, Topical

Placebo Comparator: Dose C
Placebo comparator
Biological: Placebo comparator
Placebo, Dose C, Topical




Primary Outcome Measures :
  1. Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: Week 4 ]
    Improvement at follow-up in the experimental groups compared to the placebo group

  2. Gravimetry [ Time Frame: Week 4 ]
    The amount of sweat measured gravimetrically


Secondary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565732


Locations
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United States, California
San Francisco, California, United States, 94117
Sponsors and Collaborators
Revance Therapeutics, Inc.

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02565732     History of Changes
Other Study ID Numbers: RT001-CL045
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents