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Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

This study has been completed.

Sponsored by: Mount Sinai School of Medicine
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004480
  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

MedlinePlus related topics:   Botox   

Drug Information available for:   Clostridium botulinum toxin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Diagnosis of hyperhidrosis
  • Excessive sweating in the hands, feet, armpits, forehead, or body
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004480

Locations
United States, New York
Mount Sinai School of Medicine    
      New York, New York, United States, 10029

Sponsors and Collaborators
Mount Sinai School of Medicine

Investigators
Study Chair:     Horacio Kaufmann     Mount Sinai School of Medicine    
  More Information


Study ID Numbers:   199/14182, MTS-GCO-98-913NE, ALLERGAN-MTS-GCO-98-913NE
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004480
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Botulinum Toxins
Skin Diseases
Rare Diseases
Hyperhidrosis
Botulinum Toxin Type A

Additional relevant MeSH terms:
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Sweat Gland Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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