Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

NCT ID: NCT00004480

Last Updated: 2005-06-24

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

NA

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Brief Summary

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OBJECTIVES:

I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.

Detailed Description

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PROTOCOL OUTLINE:

Patients receive injections of botulinum toxin in the clinical trial for 6 months. Patients undergo an iodine starch test and a sympathetic skin response test to assess the efficacy of the drug. Patients also complete questionnaires to evaluate the amount of sweating.

Conditions

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Hyperhidrosis

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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botulinum toxin type A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of hyperhidrosis
* Excessive sweating in the hands, feet, armpits, forehead, or body
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Principal Investigators

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Horacio Kaufmann

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MTS-GCO-98-913NE

Identifier Type: -

Identifier Source: secondary_id

ALLERGAN-MTS-GCO-98-913NE

Identifier Type: -

Identifier Source: secondary_id

199/14182

Identifier Type: -

Identifier Source: org_study_id