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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
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring dermatologic disorders, hyperhidrosis, rare disease

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
Icahn School of Medicine at Mount Sinai
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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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