Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring dermatologic disorders, hyperhidrosis, rare disease
Eligibility Criteria
Diagnosis of hyperhidrosis Excessive sweating in the hands, feet, armpits, forehead, or body
Sites / Locations
- Mount Sinai School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004480
First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00004480
Brief Title
Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES:
I. Determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
dermatologic disorders, hyperhidrosis, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
botulinum toxin type A
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of hyperhidrosis
Excessive sweating in the hands, feet, armpits, forehead, or body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Botulinum Toxin in Patients With Primary Hyperhidrosis
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