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

August 25, 2017 updated by: Allergan

Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Weeks 4, 8, 12 and 18
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.
Baseline, Weeks 4, 8, 12 and 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Joan-En Lin, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2015

Primary Completion (Actual)

February 29, 2016

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-1207-HHID-205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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