NCT00168480

Brief Summary

This is a three year open-label study in subjects with axillary hyperhidrosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_4

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

3.4 years

First QC Date

September 13, 2005

Last Update Submit

September 26, 2008

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • Assessment of axillary sweat production

    Every 4 Months

Secondary Outcomes (1)

  • Patient reported health outcome measures

    1 Month Post-Treatment Visit

Study Arms (1)

1

EXPERIMENTAL

Botulinum Toxin Type A

Biological: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ABIOLOGICAL

100 U, repeated treatments at \> 4 month intervals up to Month 32, over a 36-month study period

Also known as: BOTOX®
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Marked axillary hyperhidrosis

You may not qualify if:

  • Previous use of botulinum toxin for hyperhidrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Pinneberg, Germany

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

November 1, 2003

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

US(1)DE(1)SE(1)GB(1)