A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00168415

Purpose

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

Condition	Intervention	Phase
Hyperhidrosis	Biological: Botulinum Toxin Type A	Phase IV

MedlinePlus related topics: Botox

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Subject's assessment of the severity of hyperhidrosis using the HDS Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurement of axillary sweat production [ Time Frame: Week 4, Week 8 and any re-injection visit ] [ Designated as safety issue: No ]

Enrollment:	144
Study Start Date:	August 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Botulinum Toxin Type A	Biological: Botulinum Toxin Type A 100 U up to 6 times during the study depending on the response to treatment

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168415

Locations

United States, Oregon

Portland, Oregon, United States
Canada, British Columbia

Vancouver, British Columbia, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-075
Study First Received:	September 13, 2005
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00168415
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Botulinum Toxins
Skin Diseases
Hyperhidrosis
Botulinum Toxin Type A

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Sweat Gland Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009