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Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004480
First Posted: October 19, 1999
Last Update Posted: June 24, 2005
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.
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES:

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


Condition Intervention
Hyperhidrosis Drug: botulinum toxin type A

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: July 1999
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Diagnosis of hyperhidrosis
  • Excessive sweating in the hands, feet, armpits, forehead, or body
  Contacts and Locations
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): NCT00004480


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Study Chair: Horacio Kaufmann Icahn School of Medicine at Mount Sinai
  More Information

ClinicalTrials.gov Identifier: NCT00004480     History of Changes
Other Study ID Numbers: 199/14182
MTS-GCO-98-913NE
ALLERGAN-MTS-GCO-98-913NE
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: June 24, 2005
Last Verified: July 2004

Keywords provided by Office of Rare Diseases (ORD):
dermatologic disorders
hyperhidrosis
rare disease

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents