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

August 2, 2016 updated by: Revance Therapeutics, Inc.
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose A
Botulinum toxin type A
Biological: Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical
Biological: Botulinum toxin type A
Botulinum toxin type A, Dose B, Topical
Experimental: Dose B
Botulinum toxin type A
Biological: Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Dermatology Life Quality Index (DLQI)
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revance Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT001-CL045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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