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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014