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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799824
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Anterios Inc.

Study Description
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Brief Summary:
The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.

Condition or disease Intervention/treatment Phase
Primary Axillary Hyperhidrosis Biological: ANT-1403 Biological: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
Study Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
ANT-1403
 Biological: ANT-1403
Placebo Comparator: Vehicle
Vehicle
 Biological: placebo


Outcome Measures
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Primary Outcome Measures :
  1. HDSS [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. GSP [ Time Frame: Week 8 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799824


Locations
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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
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Responsible Party: Anterios Inc.
ClinicalTrials.gov Identifier: NCT01799824    
Other Study ID Numbers: ANT-1403-HHID-202
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases