Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
- Conditions
- Hyperhidrosis
- Interventions
- Biological: VehicleBiological: ANT-1207
- Registration Number
- NCT02479139
- Lead Sponsor
- Allergan
- Brief Summary
The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle 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. ANT-1207 Dose 1 ANT-1207 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 Dose 2 ANT-1207 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 Dose 3 ANT-1207 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 Dose 4 ANT-1207 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 Dose 5 ANT-1207 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.
- Primary Outcome Measures
Name Time Method 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% Baseline, Week 12 The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points Baseline, Weeks 4, 8, 12 and 18 The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported.Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% Baseline, Weeks 4, 8, 12 and 18 GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported.
Trial Locations
- Locations (19)
Baumann Cosmetic & Research Institute
🇺🇸Miami, Florida, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
PMG Research of Cary
🇺🇸Cary, North Carolina, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
San Marcus Research Clinic, Inc.
🇺🇸Hialeah, Florida, United States
Radiant Research, Inc.
🇺🇸Pinellas Park, Florida, United States
Research Institute of the Southeast, LLC
🇺🇸West Palm Beach, Florida, United States
William Coleman III, MD, APMC
🇺🇸Metairie, Louisiana, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Allus Clinical Research
🇺🇸Jenkintown, Pennsylvania, United States
JUVA Skin and Laser Center
🇺🇸New York, New York, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
J&S Studies, Inc.
🇺🇸College Station, Texas, United States
Virginia Clinical Research Inc.
🇺🇸Norfolk, Virginia, United States
Lupo Center for Aesthetic & General Dermatology
🇺🇸New Orleans, Louisiana, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Dermatology and Laser Center of Charleston, PA
🇺🇸Charleston, South Carolina, United States
Westlake Dermatology Clinical Research Center
🇺🇸Austin, Texas, United States