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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01799824
First received: February 25, 2013
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Primary Axillary Hyperhidrosis
Biological: ANT-1403
Biological: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults

Further study details as provided by Anterios Inc.:

Primary Outcome Measures:
  • HDSS [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GSP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
ANT-1403
Biological: ANT-1403
Placebo Comparator: Vehicle
Vehicle
Biological: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799824

Locations
United States, Florida
Miami, Florida, United States, 33137
Pinellas Park, Florida, United States, 33781
West Palm Beach, Florida, United States, 33401
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, New Jersey
East Windsor, New Jersey, United States, 08520
United States, New York
Rochester, New York, United States, 14623
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Yardley, Pennsylvania, United States, 19067
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Anterios Inc.
  More Information

No publications provided

Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01799824     History of Changes
Other Study ID Numbers: ANT-1403-HHID-202
Study First Received: February 25, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014