Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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

No publications provided

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
ClinicalTrials.gov Identifier:	NCT00004480 History of Changes
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

Peripheral Nervous System Agents
Hyperhidrosis
Botulinum Toxin Type A

Additional relevant MeSH terms:

Botulinum Toxins
Skin Diseases
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Sweat Gland Diseases
Hyperhidrosis
Botulinum Toxin Type A
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009