Clinical trial NCT02479139: Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
Official title: Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* ages 18 - 70 years of age
* 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:

* botulinum toxin treatment in the prior 6 months
* 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

Primary outcomes:
measure: Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
timeFrame: Baseline, Weeks 4, 8, 12 and 18
measure: Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
timeFrame: Baseline, Weeks 4, 8, 12 and 18
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Metairie
country: United States
facility: William Coleman III, MD, APMC
state: Louisiana
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic & General Dermatology
state: Louisiana
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: New York
country: United States
facility: JUVA Skin and Laser Center
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Jenkintown
country: United States
facility: Allus Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston, PA
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc.
state: Virginia
Study officials:
affiliation: Allergan
name: Joan-En Lin
role: STUDY_DIRECTOR
References: