NCT00168415

Brief Summary

A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Geographic Reach
2 countries

2 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

August 1, 2005

Completed
1 month 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

September 26, 2008

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • Subject's assessment of the severity of hyperhidrosis using the HDS Scale

    Monthly

Secondary Outcomes (1)

  • Measurement of axillary sweat production

    Week 4, Week 8 and any re-injection visit

Study Arms (1)

1

EXPERIMENTAL

Botulinum Toxin Type A

Biological: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ABIOLOGICAL

100 U up to 6 times during the study depending on the response to treatment

Also known as: BOTOX®
1

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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 (2)

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Glaser DA, Pariser DM, Hebert AA, Landells I, Somogyi C, Weng E, Brin MF, Beddingfield F. A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis. Pediatr Dermatol. 2015 Sep-Oct;32(5):609-17. doi: 10.1111/pde.12620. Epub 2015 Jun 8.

    PMID: 26059781DERIVED

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

August 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

US(1)CA(1)