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Botox Cosmetic and the Young Patient With Glabellar Furrows

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856999
First Posted: March 6, 2009
Last Update Posted: March 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Oregon Health and Science University
  Purpose
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Condition Intervention Phase
Glabellar Furrows Drug: Botox Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Botox Cosmetic and the Young Patient With Glabellar Furrows

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Arms Assigned Interventions
Experimental: Botox
Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Drug: Botox
Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Fitzpatrick Skin Types I-III
  • Between 30 and 50 years of age
  • At least moderate severity at maximum frown

Exclusion Criteria:

  • Prior botulinum toxin treatment
  • Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
  • Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
  • Allergy or sensitivity to any study component
  • Participation in another clinical study within 30 days of the study start date
  • Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856999


Sponsors and Collaborators
Oregon Health and Science University
Allergan
Investigators
Principal Investigator: Roger Dailey, MD Oregon Health and Science University
  More Information

Responsible Party: Roger Dailey, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00856999     History of Changes
Other Study ID Numbers: AGNR-08-0093
First Submitted: March 4, 2009
First Posted: March 6, 2009
Last Update Posted: March 6, 2009
Last Verified: March 2009

Keywords provided by Oregon Health and Science University:
Glabellar lines of moderate severity at maximum frown

Additional relevant MeSH terms:
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents