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

NCT ID: NCT01799824

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Primary Axillary Hyperhidrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

ANT-1403

Group Type EXPERIMENTAL

ANT-1403

Intervention Type BIOLOGICAL

Vehicle

Vehicle

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Interventions

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ANT-1403

Intervention Type BIOLOGICAL

placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anterios Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Miami, Florida, United States

Site Status

Pinellas Park, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Louisville, Kentucky, United States

Site Status

East Windsor, New Jersey, United States

Site Status

Rochester, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Yardley, Pennsylvania, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ANT-1403-HHID-202

Identifier Type: -

Identifier Source: org_study_id