Study of Botulinum Toxin in Patients With Primary Hyperhi... | NCT00004480

Studies
Study of Botulinum Toxin in Patients With Primary Hyperhidrosis

NCT00004480

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Hyperhidrosis

Interventions

botulinum toxin type A

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
botulinum toxin type A	Drug

Eligibility Module

Eligibility Criteria

Diagnosis of hyperhidrosis
Excessive sweating in the hands, feet, armpits, forehead, or body

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horacio Kaufmann	Icahn School of Medicine at Mount Sinai	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai School of Medicine		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D006945	Hyperhidrosis
D012871	Skin Diseases
D035583	Rare Diseases

Ancestor Terms

ID	Term
D013543	Sweat Gland Diseases
D017437	Skin and Connective Tissue Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MTS-GCO-98-913NE
ALLERGAN-MTS-GCO-98-913NE