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

November 15, 2013 updated by: Anterios Inc.

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

The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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
      • Miami, Florida, United States, 33137
      • Pinellas Park, Florida, United States, 33781
      • West Palm Beach, Florida, United States, 33401
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
    • New York
      • Rochester, New York, United States, 14623
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
    • Pennsylvania
      • Yardley, Pennsylvania, United States, 19067
    • Virginia
      • Norfolk, Virginia, United States, 23507

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 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Biological: placebo
Experimental: Active
ANT-1403
Biological: ANT-1403

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HDSS
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
GSP
Time Frame: Week 8
Week 8

Collaborators and Investigators

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

Sponsor

Anterios Inc.

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

February 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANT-1403-HHID-202

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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