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Completed

NCT Number: NCT01799824

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

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

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Key information

Conditions

Primary Axillary Hyperhidrosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANT-1403

Biological

Placebo

Biological

Primary outcomes

  1. HDSS

    Time frame: Week 8

Secondary outcomes

  1. GSP

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Anterios Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2013
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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