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
Study 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 January 16, 2009