Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
Hyperhidrosis
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- San Marcus Research Clinic, Inc.
- Baumann Cosmetic & Research Institute
- Radiant Research, Inc.
- Research Institute of the Southeast, LLC
- Shideler Clinical Research Center
- William Coleman III, MD, APMC
- Lupo Center for Aesthetic & General Dermatology
- Skin Specialists, PC
- JUVA Skin and Laser Center
- Skin Search of Rochester, Inc.
- PMG Research of Cary
- Allus Clinical Research
- Dermatology and Laser Center of Charleston, PA
- The Skin Wellness Center
- Tennessee Clinical Research Center
- Westlake Dermatology Clinical Research Center
- J&S Studies, Inc.
- Texas Dermatology and Laser Specialists
- Virginia Clinical Research Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Vehicle
ANT-1207 Dose 1
ANT-1207 Dose 2
ANT-1207 Dose 3
ANT-1207 Dose 4
ANT-1207 Dose 5
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.
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.
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.
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.
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.
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.