Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
NCT ID: NCT02479139
Last Updated: 2017-09-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2015-06-03
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle
Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
Vehicle
Vehicle for ANT-1207 liniment formulation without active ingredient.
ANT-1207 Dose 1
Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
ANT-1207 Dose 2
Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
ANT-1207 Dose 3
Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
ANT-1207 Dose 4
Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
ANT-1207 Dose 5
Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
Interventions
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Vehicle
Vehicle for ANT-1207 liniment formulation without active ingredient.
ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).
Eligibility Criteria
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Inclusion Criteria
* diagnosis of primary axillary hyperhidrosis
* HDSS score of ≥3
* threshold sweat production/axilla in 5 minutes as measured gravimetrically
* willingness to shave underarms prior to each study visit
Exclusion Criteria
* signs of infection in the axilla
* skin affliction in the axilla requiring medical treatment
* oral anticholinergic treatment
* use of antiperspirants, deodorants, powders, or lotions
* use of axillary depilatories or axillary epilation
* history of surgery or other interventions for axillary hyperhidrosis
* female subjects who are pregnant or are nursing a child
18 Years
70 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Joan-En Lin
Role: STUDY_DIRECTOR
Allergan
Locations
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San Marcus Research Clinic, Inc.
Hialeah, Florida, United States
Baumann Cosmetic & Research Institute
Miami, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
William Coleman III, MD, APMC
Metairie, Louisiana, United States
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, United States
Skin Specialists, PC
Omaha, Nebraska, United States
JUVA Skin and Laser Center
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
PMG Research of Cary
Cary, North Carolina, United States
Allus Clinical Research
Jenkintown, Pennsylvania, United States
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, United States
J&S Studies, Inc.
College Station, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ANT-1207-HHID-205
Identifier Type: -
Identifier Source: org_study_id