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

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle
ANT-1207
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Vehicle

ANT-1207 Dose 1

ANT-1207 Dose 2

ANT-1207 Dose 3

ANT-1207 Dose 4

ANT-1207 Dose 5

Arm Description

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.

Outcomes

Primary Outcome Measures

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%
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

Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
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%
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.

Full Information

First Posted
June 19, 2015
Last Updated
August 25, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02479139
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
ANT-1207 Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
ANT-1207 Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
ANT-1207 Dose 3
Arm Type
Experimental
Arm Description
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.
Arm Title
ANT-1207 Dose 4
Arm Type
Experimental
Arm Description
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.
Arm Title
ANT-1207 Dose 5
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
Vehicle for ANT-1207 liniment formulation without active ingredient.
Intervention Type
Biological
Intervention Name(s)
ANT-1207
Intervention Description
Botulinum toxin Type A topical liniment (ANT-1207).
Primary Outcome Measure Information:
Title
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%
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12 and 18
Title
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12 and 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan-En Lin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
San Marcus Research Clinic, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Baumann Cosmetic & Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Research Institute of the Southeast, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
William Coleman III, MD, APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Lupo Center for Aesthetic & General Dermatology
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
JUVA Skin and Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Allus Clinical Research
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Dermatology and Laser Center of Charleston, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Westlake Dermatology Clinical Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Virginia Clinical Research Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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

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