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Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis

Primary Purpose

Primary Axillary Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ANT-1403
placebo
Sponsored by
Anterios Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Axillary 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 moderate to severe primary axillary hyperhidrosis
  • ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
  • HDSS score of ≥3

Exclusion Criteria:

  • diagnosis of secondary hyperhidrosis
  • skin affliction in the axilla requiring medical treatment
  • 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
  • oral anticholinergic treatment
  • botulinum toxin treatment in the prior 9 months
  • history of surgery for axillary hyperhidrosis
  • present or history of neuromuscular disease
  • female subjects who are pregnant or are nursing a child

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Vehicle

Arm Description

ANT-1403

Vehicle

Outcomes

Primary Outcome Measures

HDSS

Secondary Outcome Measures

GSP

Full Information

First Posted
February 25, 2013
Last Updated
November 15, 2013
Sponsor
Anterios Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01799824
Brief Title
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis
Official Title
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anterios Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to confirm the effect of ANT-1403 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
Primary Axillary Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
ANT-1403
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Biological
Intervention Name(s)
ANT-1403
Intervention Type
Biological
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
HDSS
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
GSP
Time Frame
Week 8

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 moderate to severe primary axillary hyperhidrosis ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically HDSS score of ≥3 Exclusion Criteria: diagnosis of secondary hyperhidrosis skin affliction in the axilla requiring medical treatment 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline oral anticholinergic treatment botulinum toxin treatment in the prior 9 months history of surgery for axillary hyperhidrosis present or history of neuromuscular disease female subjects who are pregnant or are nursing a child
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis

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