Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
NCT ID: NCT02565732
Last Updated: 2016-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2015-09-30
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis
NCT01128738
Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
NCT00004480
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis
NCT00168415
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
NCT00168402
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
NCT00168480
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose A
Botulinum toxin type A
Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical
Dose B
Botulinum toxin type A
Botulinum toxin type A
Botulinum toxin type A, Dose B, Topical
Dose C
Placebo comparator
Placebo comparator
Placebo, Dose C, Topical
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical
Botulinum toxin type A
Botulinum toxin type A, Dose B, Topical
Placebo comparator
Placebo, Dose C, Topical
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Revance Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RT001-CL045
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.