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Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02479139
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Biological: Vehicle Biological: ANT-1207 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults
Actual Study Start Date : June 3, 2015
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Placebo Comparator: 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.
Biological: Vehicle
Vehicle for ANT-1207 liniment formulation without active ingredient.

Experimental: 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.
Biological: ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).

Experimental: 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.
Biological: ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).

Experimental: 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.
Biological: ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).

Experimental: 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.
Biological: ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).

Experimental: 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.
Biological: ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).




Primary Outcome Measures :
  1. 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% [ Time Frame: 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 :
  1. Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points [ Time Frame: 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.


  2. Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479139


Locations
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United States, Florida
San Marcus Research Clinic, Inc.
Hialeah, Florida, United States, 33015
Baumann Cosmetic & Research Institute
Miami, Florida, United States, 33137
Radiant Research, Inc.
Pinellas Park, Florida, United States, 33781
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States, 33401
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
United States, Louisiana
William Coleman III, MD, APMC
Metairie, Louisiana, United States, 70006
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, United States, 70124
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New York
JUVA Skin and Laser Center
New York, New York, United States, 10021
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
United States, North Carolina
PMG Research of Cary
Cary, North Carolina, United States, 27518
United States, Pennsylvania
Allus Clinical Research
Jenkintown, Pennsylvania, United States, 19046
United States, South Carolina
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, United States, 29414
United States, Tennessee
The Skin Wellness Center
Knoxville, Tennessee, United States, 37922
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
J&S Studies, Inc.
College Station, Texas, United States, 77845
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
United States, Virginia
Virginia Clinical Research Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joan-En Lin Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02479139     History of Changes
Other Study ID Numbers: ANT-1207-HHID-205
First Posted: June 24, 2015    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents