Botox Cosmetic and the Young Patient With Glabellar Furrows

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00856999
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 4, 2009
March 4, 2009
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No Changes Posted
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Botox Cosmetic and the Young Patient With Glabellar Furrows
Botox Cosmetic and the Young Patient With Glabellar Furrows

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.

Not Provided
Interventional
Phase 4
Primary Purpose: Treatment
Glabellar Furrows
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
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
Intervention: Drug: Botox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Female
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00856999
AGNR-08-0093
No
Roger Dailey, Oregon Health & Science University
Oregon Health and Science University
Allergan
Principal Investigator: Roger Dailey, MD Oregon Health and Science University
Oregon Health and Science University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP