Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004480
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2004
  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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

No publications provided

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

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014