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A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168415
First received: September 13, 2005
Last updated: September 26, 2008
Last verified: September 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Hyperhidrosis
 Biological: Botulinum Toxin Type A
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

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
Experimental: 1
Botulinum Toxin Type A
 Biological: Botulinum Toxin Type A
100 U up to 6 times during the study depending on the response to treatment
Other Name: BOTOX®

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Marked axillary hyperhidrosis

Exclusion Criteria:

  • Previous use of botulinum toxin for hyperhidrosis
  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

No publications provided

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

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013